Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213098
Company: ZYDUS WORLDWIDE DMCC

Products on ANDA 213098

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PALBOCICLIB	PALBOCICLIB	UNKNOWN	UNKNOWN	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213098

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2020	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.