Is Advagen Pharma Limited FDA approved?

Advagen Pharma Limited holds no registered establishment of its own; 213 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Advagen Pharma Limited make?

213 products are listed under Advagen Pharma Limited in the openFDA NDC Directory, most often as tablet; tablet, film coated; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Advagen Pharma Limited

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 213
Labeller names: 5
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

213

213 active NDC listings: 207 human prescription drug, 6 human otc drug. By marketing category: ANDA 207, NDA AUTHORIZED GENERIC 5, OTC MONOGRAPH DRUG 1.

Dosage form	NDCs
tablet	86
tablet, film coated	36
solution	17
tablet, extended release	15
capsule	12
tablet, coated	7
tablet, delayed release	6
tablet, film coated, extended release	6
tablet, orally disintegrating	6
capsule, extended release	4
suspension	4
injection	3
spray	3
concentrate	2
lozenge	2

Route	NDCs
oral	194
sublingual	7
nasal	5
ophthalmic	4
intrathecal	3
topical	1

Labeller name on the listing	NDCs
advagen pharma ltd	101
advagen pharma limited	77
advagen pharma ltd.	25
advagen pharma ltd.,	9
advagen pharma limited	1

Catalogue

Marketed products

213

Showing 150 of 213.

Brand	Generic name	Form / route	NDC
Acetazolamide	Acetazolamide	tablet, oral	72888-047ANDA
Acetazolamide	Acetazolamide	tablet, oral	72888-048ANDA
Acyclovir	Acyclovir	suspension, oral	72888-079ANDA
Amantadine Hydrochloride	Amantadine Hydrochloride	capsule, oral	72888-033ANDA
Amiodarone Hydrochloride	Amiodarone Hydrochloride	tablet, oral	72888-039ANDA
Amiodarone Hydrochloride	Amiodarone Hydrochloride	tablet, oral	72888-060ANDA
Amiodarone Hydrochloride	Amiodarone Hydrochloride	tablet, oral	72888-061ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	72888-067ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	72888-068ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	72888-069ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	72888-070ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	72888-071ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	72888-072ANDA
Aripiprazole	Aripiprazole	solution, oral	72888-100ANDA
Atomoxetine hydrochloride	Atomoxetine hydrochloride	solution, oral	72888-456NDA AUTHORIZED GENERIC
BACLOFEN	BACLOFEN	tablet, oral	72888-009ANDA
BACLOFEN	BACLOFEN	tablet, oral	72888-010ANDA
BACLOFEN	BACLOFEN	tablet, oral	72888-011ANDA
BACLOFEN	Baclofen	solution, oral	72888-103ANDA
BACLOFEN	Baclofen	injection, intrathecal	72888-145ANDA
BACLOFEN	Baclofen	injection, intrathecal	72888-146ANDA
BACLOFEN	Baclofen	injection, intrathecal	72888-147ANDA
BACLOFEN	BACLOFEN	tablet, oral	72888-202ANDA
Baclofen	Baclofen	solution, oral	72888-466ANDA
Bisoprolol Fumarate	Bisoprolol Fumarate	tablet, film coated, oral	72888-092ANDA
Bisoprolol Fumarate	Bisoprolol Fumarate	tablet, film coated, oral	72888-093ANDA
Bisoprolol Fumarate	Bisoprolol Fumarate	tablet, film coated, oral	72888-233ANDA
Bumetanide	Bumetanide	tablet, oral	72888-019ANDA
Bumetanide	Bumetanide	tablet, oral	72888-020ANDA
Bumetanide	Bumetanide	tablet, oral	72888-021ANDA
CARVEDILOL	CARVEDILOL	tablet, film coated, oral	72888-034ANDA
CARVEDILOL	CARVEDILOL	tablet, film coated, oral	72888-035ANDA
CARVEDILOL	CARVEDILOL	tablet, film coated, oral	72888-036ANDA
CARVEDILOL	CARVEDILOL	tablet, film coated, oral	72888-037ANDA
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	capsule, oral	72888-118ANDA
CHILDRENS IBUPROFEN	Ibuprofen	suspension, oral	72888-479ANDA
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	solution, ophthalmic	72888-102ANDA
CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	tablet, film coated, oral	72888-012ANDA
CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	tablet, film coated, oral	72888-013ANDA
CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	tablet, film coated, oral	72888-014ANDA
Carbidopa and levodopa	Carbidopa and levodopa	tablet, extended release, oral	72888-155ANDA
Carbidopa and levodopa	Carbidopa and levodopa	tablet, extended release, oral	72888-156ANDA
Carbidopa-levodopa	carbidopa and levodopa	tablet, oral	72888-106ANDA
Carbidopa-levodopa	carbidopa and levodopa	tablet, oral	72888-107ANDA
Carbidopa-levodopa	carbidopa and levodopa	tablet, oral	72888-108ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	72888-499ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	72888-500ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	72888-501ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	72888-502ANDA
Cetirizine hydrochloride	Cetirizine hydrochloride	solution, oral	72888-480ANDA
Childrens Acetaminophen	Acetaminophen	suspension, oral	72888-459OTC MONOGRAPH DRUG
Clomiphene Citrate	Clomiphene Citrate	tablet, oral	72888-213ANDA
Clonazepam	Clonazepam	tablet, oral	72888-152ANDA
Clonazepam	Clonazepam	tablet, oral	72888-153ANDA
Clonazepam	Clonazepam	tablet, oral	72888-154ANDA
Clonazepam	Clonazepam	tablet, oral	72888-497ANDA
DESVENLAFAXINE	DESVENLAFAXINE	tablet, extended release, oral	72888-143ANDA
DESVENLAFAXINE	DESVENLAFAXINE	tablet, extended release, oral	72888-144ANDA
DESVENLAFAXINE	DESVENLAFAXINE	tablet, extended release, oral	72888-175ANDA
DEXAMETHASONE	DEXAMETHASONE	tablet, oral	72888-235ANDA
DEXAMETHASONE	DEXAMETHASONE	tablet, oral	72888-236ANDA
DEXAMETHASONE	DEXAMETHASONE	tablet, oral	72888-237ANDA
DEXAMETHASONE	DEXAMETHASONE	tablet, oral	72888-238ANDA
DEXAMETHASONE	DEXAMETHASONE	tablet, oral	72888-239ANDA
DEXAMETHASONE	DEXAMETHASONE	tablet, oral	72888-240ANDA
DEXAMETHASONE	DEXAMETHASONE	tablet, oral	72888-241ANDA
DICLOFENAC SODIUM	DICLOFENAC SODIUM	solution, ophthalmic	72888-150ANDA
DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	solution, ophthalmic	72888-077ANDA
Diclofenac Potassium	diclofenac potassium	tablet, coated, oral	72888-073ANDA
Diclofenac Potassium	diclofenac potassium	tablet, coated, oral	72888-086ANDA
Diclofenac Potassium	diclofenac potassium	tablet, coated, oral	72888-203ANDA
Diclofenac Sodium	Diclofenac Sodium	tablet, delayed release, oral	72888-109ANDA
Diclofenac Sodium	Diclofenac Sodium	tablet, delayed release, oral	72888-110ANDA
Diclofenac Sodium	Diclofenac Sodium	tablet, delayed release, oral	72888-111ANDA
Dicyclomine hydrochloride	Dicyclomine hydrochloride	capsule, oral	72888-105ANDA
Dicyclomine hydrochloride	Dicyclomine hydrochloride	tablet, oral	72888-119ANDA
Dicyclomine hydrochloride	Dicyclomine hydrochloride	tablet, oral	72888-198ANDA
Dihydroergotamine mesylate	Dihydroergotamine mesylate	spray, nasal	72888-096ANDA
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	spray, nasal	72888-141ANDA
Fluticasone Propionate	Fluticasone Propionate Nasal	spray, nasal	72888-248ANDA
GUANFACINE	GUANFACINE	tablet, extended release, oral	72888-224ANDA
GUANFACINE	GUANFACINE	tablet, extended release, oral	72888-225ANDA
GUANFACINE	GUANFACINE	tablet, extended release, oral	72888-226ANDA
GUANFACINE	GUANFACINE	tablet, extended release, oral	72888-227ANDA
Gabapentin	gabapentin	solution, oral	72888-104ANDA
Gabapentin	gabapentin	tablet, oral	72888-131ANDA
Gabapentin	gabapentin	tablet, oral	72888-132ANDA
Glipizide	Glipizide	tablet, oral	72888-115ANDA
Glipizide	Glipizide	tablet, oral	72888-116ANDA
Glipizide	Glipizide	tablet, oral	72888-117ANDA
Glipizide	Glipizide	tablet, oral	72888-231ANDA
Guanfacine	Guanfacine	tablet, oral	72888-123ANDA
Guanfacine	Guanfacine	tablet, oral	72888-124ANDA
Haloperidol	Haloperidol	solution, concentrate, oral	72888-173ANDA
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	spray, metered, nasal	72888-148ANDA
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	spray, metered, nasal	72888-149ANDA
ISOSORBIDE DINITRATE	isosorbide dinitrate	tablet, oral	72888-081ANDA
ISOSORBIDE DINITRATE	isosorbide dinitrate	tablet, oral	72888-082ANDA
ISOSORBIDE DINITRATE	isosorbide dinitrate	tablet, oral	72888-083ANDA
ISOSORBIDE DINITRATE	isosorbide dinitrate	tablet, oral	72888-084ANDA
ISOSORBIDE DINITRATE	isosorbide dinitrate	tablet, oral	72888-085ANDA
Ivermectin	Ivermectin	tablet, oral	72888-206ANDA
Ivermectin	Ivermectin	tablet, oral	72888-207ANDA
LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	tablet, film coated, oral	72888-120ANDA
LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	tablet, film coated, oral	72888-121ANDA
LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	tablet, film coated, oral	72888-122ANDA
LABETALOL HYDROCHLORIDE	Labetalol Hydrochloride	tablet, film coated, oral	72888-468ANDA
LEVOFLOXACIN	LEVOFLOXACIN	solution, ophthalmic	72888-142ANDA
LORATADINE	LORATADINE	tablet, orally disintegrating, oral	72888-029ANDA
Lamotrigine	Lamotrigine	tablet, oral	72888-025ANDA
Lamotrigine	Lamotrigine	tablet, oral	72888-026ANDA
Lamotrigine	Lamotrigine	tablet, oral	72888-027ANDA
Lamotrigine	Lamotrigine	tablet, oral	72888-028ANDA
Lidocaine hydrochloride	Lidocaine hydrochloride	solution, oral, topical	72888-125ANDA
Lithium	Lithium	solution, oral	72888-172ANDA
Loperamide Hydrochloride	Loperamide Hydrochloride	capsule, oral	72888-130ANDA
METOLAZONE	METOLAZONE	tablet, oral	72888-052ANDA
METOLAZONE	METOLAZONE	tablet, oral	72888-053ANDA
METOLAZONE	METOLAZONE	tablet, oral	72888-054ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, film coated, oral	72888-004ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, film coated, oral	72888-005ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, film coated, oral	72888-006ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, film coated, oral	72888-023ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, film coated, oral	72888-101ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, oral	72888-208ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, oral	72888-209ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, oral	72888-210ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, oral	72888-211ANDA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	tablet, oral	72888-212ANDA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	tablet, oral	72888-185ANDA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	capsule, oral	72888-192ANDA
Metoprolol Tartrate	METOPROLOL TARTRATE	tablet, oral	72888-197NDA AUTHORIZED GENERIC
Midodrine Hydrochloride	Midodrine Hydrochloride	tablet, oral	72888-112ANDA
Midodrine Hydrochloride	Midodrine Hydrochloride	tablet, oral	72888-113ANDA
Midodrine Hydrochloride	Midodrine Hydrochloride	tablet, oral	72888-114ANDA
Nicotine Mini	Nicotine Polacrilex	lozenge, oral	72888-186ANDA
Nicotine Mini	Nicotine Polacrilex	lozenge, oral	72888-187ANDA
Nitroglycerin	nitroglycerin	tablet, sublingual	72888-138ANDA
Nitroglycerin	nitroglycerin	tablet, sublingual	72888-139ANDA
Nitroglycerin	nitroglycerin	tablet, sublingual	72888-140ANDA
Nortriptyline Hydrochloride	Nortriptyline Hydrochloride	solution, oral	72888-157ANDA
OXCARBAZEPINE	OXCARBAZEPINE	suspension, oral	72888-074ANDA
Oxcarbazepine	oxcarbazepine	tablet, film coated, oral	72888-087ANDA
Oxcarbazepine	oxcarbazepine	tablet, film coated, oral	72888-088ANDA
Oxcarbazepine	oxcarbazepine	tablet, film coated, oral	72888-089ANDA
Oxcarbazepine	Oxcarbazepine	tablet, oral	72888-460ANDA
Oxcarbazepine	Oxcarbazepine	tablet, oral	72888-461ANDA
Oxcarbazepine	Oxcarbazepine	tablet, oral	72888-462ANDA
Oxybutynin Chloride	Oxybutynin Chloride	tablet, extended release, oral	72888-030ANDA
Oxybutynin Chloride	Oxybutynin Chloride	tablet, extended release, oral	72888-031ANDA

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Enquiry

Common questions

Is Advagen Pharma Limited FDA approved?: Advagen Pharma Limited holds no registered establishment of its own; 213 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Advagen Pharma Limited make?: 213 products are listed under Advagen Pharma Limited in the openFDA NDC Directory, most often as tablet; tablet, film coated; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.