Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204902
Company: BARADAINA LLC

Products on ANDA 204902

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPIPRAZOLE HYDROCHLORIDE	DAPIPRAZOLE HYDROCHLORIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204902

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204902Orig1s000ltr.pdf