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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 218196

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NDA 218196 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 twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.

Summary for 218196

Tradename:	BIMATOPROST
Applicant:	Mankind Pharma
Ingredient:	bimatoprost
Patents:	0

Pharmacology for NDA: 218196

Medical Subject Heading (MeSH) Categories for 218196

Antihypertensive Agents

Suppliers and Packaging for NDA: 218196

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	218196	ANDA	Lifestar Pharma LLC	70756-626	70756-626-30	1 BOTTLE in 1 CARTON (70756-626-30) / 2.5 mL in 1 BOTTLE
BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	218196	ANDA	Lifestar Pharma LLC	70756-627	70756-627-30	1 BOTTLE in 1 CARTON (70756-627-30) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.01%
Approval Date:	Mar 17, 2025	TE:	AB	RLD:	No

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