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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218437
Company: ANNORA PHARMA PRIVATE LIMITED

Products on ANDA 218437

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOFACITINIB	TOFACITINIB	10MG	TABLET	None (Tentative Approval)	None	No	No
TOFACITINIB	TOFACITINIB	5MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218437

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/2024	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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