An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 218196
Company: MANKIND PHARMA

Products on ANDA 218196

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIMATOPROST	BIMATOPROST	0.01%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218196

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218196

BIMATOPROST

SOLUTION/DROPS;OPHTHALMIC; 0.01%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIMATOPROST	BIMATOPROST	0.01%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	217289	AMNEAL
BIMATOPROST	BIMATOPROST	0.01%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	218196	MANKIND PHARMA
LUMIGAN	BIMATOPROST	0.01%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AB	022184	ABBVIE

Top