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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203991
Company: LUPIN LTD

Products on ANDA 203991

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203991

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2022	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/02/2022	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/24/2020	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
11/02/2022	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203991

BIMATOPROST

SOLUTION/DROPS;OPHTHALMIC; 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;OPHTHALMIC	Prescription	No	AT	210263	ALEMBIC
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	090449	APOTEX
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	205537	EUGIA PHARMA
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	210126	GLAND PHARMA LTD
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	203991	LUPIN LTD
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202505	MICRO LABS
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202565	SANDOZ
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	207601	SOMERSET THERAPS LLC

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