Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204638
Company: MICRO LABS LTD INDIA

Products on ANDA 204638

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIMATOPROST	BIMATOPROST	0.01%	SOLUTION/DROPS;OPHTHALMIC	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204638

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2021	ORIG-1	Tentative Approval				Label is not available on this site.