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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202505
Company: MICRO LABS

Products on ANDA 202505

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 202505

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/2020	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202505

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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