Is Thea Pharma, Inc. FDA approved?

Thea Pharma, Inc. holds 1 FDA-registered establishment in the United States. 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 Thea Pharma, Inc.'s drugs manufactured?

The FDA register lists Waltham, MA. Registered operations: labelling, finished drug manufacture, packaging.

What drugs does Thea Pharma, Inc. make?

11 products are listed under Thea Pharma, Inc. in the openFDA NDC Directory, most often as solution/ drops; gel. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Thea Pharma, Inc.

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

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Registered sites: 1
Active NDC listings: 11
Live patents: 7
Exclusivities: 2
Countries: 1
Base: United States

Authorisation

Registered operations

Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Thea Pharma, Inc.	303 Wyman St, Waltham, Massachusetts (MA) 02451-1208, United States (USA)	Labelling, Finished drug manufacture, Packaging	3022351866117787029

Catalogue

Drug listings by form and route

11 active NDC listings: 9 human prescription drug, 2 human otc drug. By marketing category: NDA 9, OTC MONOGRAPH DRUG 2.

Dosage form	NDCs
solution/ drops	8
gel	3

Route	NDCs
ophthalmic	11

Labeller name on the listing	NDCs
thea pharma inc.	11

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10864159	ZIOPTANtafluprost	product	May 2029
9999593	ZIOPTANtafluprost	product	May 2029
8637054	IYUZEHlatanoprost	product	Jul 2031
10314780	ZOLYMBUSbimatoprost	product	Jun 2036
11096922	CYKLXarticaine hydrochloride	product	Mar 2039
11826347	CYKLXarticaine hydrochloride	product	Mar 2039
12403126	CYKLXarticaine hydrochloride	product	Mar 2039

Product	Exclusivity	Until
CYKLXARTICAINE HYDROCHLORIDE	NP New product	Aug 2028
ZOLYMBUSBIMATOPROST	NDF	Sept 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AKTEN	LIDOCAINE HYDROCHLORIDE ANHYDROUS	gel, ophthalmic	82584-792NDA
AZASITE	azithromycin monohydrate	solution/ drops, ophthalmic	82584-307NDA
BETIMOL	timolol	solution/ drops, ophthalmic	82584-001NDA
BETIMOL	timolol	solution/ drops, ophthalmic	82584-002NDA
COSOPT	dorzolamide hydrochloride and timolol maleate	solution/ drops, ophthalmic	82584-605NDA
COSOPT PF	dorzolamide hydrochloride and timolol maleate	solution/ drops, ophthalmic	82584-604NDA
IYUZEH	Latanoprost Ophthalmic Solution 0.005%	solution/ drops, ophthalmic	82584-003NDA
ZIOPTAN	Tafluprost	solution/ drops, ophthalmic	82584-609NDA
ZOLYMBUS	bimatoprost	gel, ophthalmic	82584-010NDA
iVIZIA Dry Eye	povidone	solution/ drops, ophthalmic	82584-700OTC MONOGRAPH DRUG
iVIZIA Lubricant Eye Gel	povidone	gel, ophthalmic	82584-701OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Aimmune Therapeutics Manufacturing, LLCWaltham, MA

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Enquiry

Common questions

Is Thea Pharma, Inc. FDA approved?: Thea Pharma, Inc. holds 1 FDA-registered establishment in the United States. 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 Thea Pharma, Inc.'s drugs manufactured?: The FDA register lists Waltham, MA. Registered operations: labelling, finished drug manufacture, packaging.
What drugs does Thea Pharma, Inc. make?: 11 products are listed under Thea Pharma, Inc. in the openFDA NDC Directory, most often as solution/ drops; gel. 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.