Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210515
Company: ALEMBIC

Products on ANDA 210515

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210515

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/28/2023	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/28/2023	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210515

BIMATOPROST

SOLUTION/DROPS;TOPICAL; 0.03%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	No	AT	210515	ALEMBIC
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	No	AT	201894	APOTEX
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	No	AT	202719	SANDOZ
LATISSE	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	Yes	AT	022369	ABBVIE