Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209464
Company: ZYDUS PHARMS USA INC

Products on ANDA 209464

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORCASERIN HYDROCHLORIDE	LORCASERIN HYDROCHLORIDE	10MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209464

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/02/2019	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209464Orig1s000TAltr.pdf