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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 207601

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NDA 207601 describes BIMATOPROST, which is a drug marketed by Alembic, Amneal, Apotex, Eugia Pharma, Gland, Hikma, Lupin Ltd, Mankind Pharma, Micro Labs, Sandoz, and Somerset Theraps Llc, and is included in fifteen NDAs. It is available from eleven suppliers. Additional details are available on the BIMATOPROST profile page.

The generic ingredient in BIMATOPROST is bimatoprost. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.

Summary for 207601

Tradename:	BIMATOPROST
Applicant:	Somerset Theraps Llc
Ingredient:	bimatoprost
Patents:	0

Pharmacology for NDA: 207601

Medical Subject Heading (MeSH) Categories for 207601

Antihypertensive Agents

Suppliers and Packaging for NDA: 207601

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	207601	ANDA	Somerset Therapeutics, LLC	70069-401	70069-401-01	1 BOTTLE in 1 CARTON (70069-401-01) / 2.5 mL in 1 BOTTLE
BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	207601	ANDA	Somerset Therapeutics, LLC	70069-402	70069-402-01	1 BOTTLE in 1 CARTON (70069-402-01) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.03%
Approval Date:	Jun 19, 2019	TE:	AT	RLD:	No

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