Register entry
- Registered sites
- 2
- Active NDC listings
- 17
- Live patents
- 3
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing2Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Novitium Labs Private LimitedRegistrant: Novitium Pharma LLC | Module 20, SIDCO MultiStoreyed Complex SIDCO IndEst, Thirumazhisai, Chennai, TN 600124, India (IND) | Analytical testing | 3013306721675488649 |
| Novitium Pharma LLC | 406 Wyckoff Mills Rd, East Windsor, New Jersey (NJ) 08520, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3012541241145067329 |
Catalogue
Drug listings by form and route
1717 active NDC listings: 17 human prescription drug. By marketing category: ANDA 17.
| Dosage form | NDCs |
|---|---|
| tablet | 10 |
| solution | 4 |
| capsule | 2 |
| suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 15 |
| topical | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| novitium pharma llc | 17 |
Exclusivity
Patents and exclusivities
3| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 11224572 | TEZRULYterazosin hydrochloride | product | Feb 2041 |
| 12427108 | TEZRULYterazosin hydrochloride | product | Feb 2041 |
| 11878022 | INZIRQOhydrochlorothiazide | product | Jan 2044 |
Catalogue
Marketed products
17| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Bisoprolol Fumarate | Bisoprolol Fumarate | tablet, oral | 70954-455ANDA |
| Bisoprolol Fumarate | Bisoprolol Fumarate | tablet, oral | 70954-456ANDA |
| Chlorzoxazone | Chlorzoxazone | tablet, oral | 70954-085ANDA |
| Clotrimazole | Clotrimazole topical | solution, topical | 70954-036ANDA |
| Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | solution, oral | 70954-261ANDA |
| Estazolam | Estazolam | tablet, oral | 70954-480ANDA |
| Estazolam | Estazolam | tablet, oral | 70954-481ANDA |
| Felbamate | Felbamate | suspension, oral | 70954-051ANDA |
| Fludrocortisone Acetate | Fludrocortisone Acetate | tablet, oral | 70954-252ANDA |
| Lidocaine Hydrochloride | Lidocaine Hydrochloride | solution, topical | 70954-518ANDA |
| Phenoxybenzamine Hydrochloride | Phenoxybenzamine Hydrochloride | capsule, oral | 70954-365ANDA |
| Pyridostigmine | Pyridostigmine bromide oral | solution, oral | 70954-148ANDA |
| Selegiline Hydrochloride | Selegiline Hydrochloride | capsule, oral | 70954-504ANDA |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | tablet, oral | 70954-211ANDA |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | tablet, oral | 70954-212ANDA |
| Tranylcypromine | Tranylcypromine | tablet, oral | 70954-538ANDA |
| Trimethoprim | Trimethoprim | tablet, oral | 70954-541ANDA |
Neighbours
Registered in the same town
12- Par Health USA, LLCChennai, IND · 2 sites
- NATCO PHARMA LIMITEDChennai, IND
- HOVIONE FARMACIENCIA, S.A.East Windsor, NJ
- Aurolife Pharma LLCEast Windsor, NJ
- Pharmazell (India) Private LimitedChennai, IND
- Apnar Pharma Private LimitedEAST WINDSOR, NJ
- Esjay Pharma Private LimitedEast Windsor, NJ
- RK Pharma IncEast Windsor, NJ
- FOURRTS INDIA LABORATORIES PRIVATE LIMITEDChennai, IND
- INGA PHARMACEUTICALSChennai, IND
- InterMed Laboratories Private LimitedCHENNAI, IND
- MOLCLONE LABS PRIVATE LIMITEDChennai, IND
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Enquiry
Common questions
- Is Novitium Pharma LLC FDA approved?
- Novitium Pharma LLC holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Novitium Pharma LLC's drugs manufactured?
- At registered sites in India, the United States. The FDA register lists Chennai; East Windsor, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Novitium Pharma LLC make?
- 17 products are listed under Novitium Pharma LLC in the openFDA NDC Directory, most often as tablet; solution; capsule. 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.