Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212980
Company: CIPLA LIMITED

Products on ANDA 212980

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PALBOCICLIB	PALBOCICLIB	75MG	CAPSULE	None (Tentative Approval)	None	No	No
PALBOCICLIB	PALBOCICLIB	125MG	CAPSULE	None (Tentative Approval)	None	No	No
PALBOCICLIB	PALBOCICLIB	100MG	CAPSULE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212980

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.