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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 202505

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NDA 202505 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 202505

Tradename:	BIMATOPROST
Applicant:	Micro Labs
Ingredient:	bimatoprost
Patents:	0

Pharmacology for NDA: 202505

Medical Subject Heading (MeSH) Categories for 202505

Antihypertensive Agents

Suppliers and Packaging for NDA: 202505

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	202505	ANDA	Micro Labs Limited	42571-128	42571-128-21	1 BOTTLE in 1 CARTON (42571-128-21) / 5 mL in 1 BOTTLE
BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	202505	ANDA	Micro Labs Limited	42571-128	42571-128-28	1 BOTTLE in 1 CARTON (42571-128-28) / 7.5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.03%
Approval Date:	Sep 8, 2020	TE:	AT	RLD:	No

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