Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216878
Company: SLAYBACK PHARMA LLC

Products on ANDA 216878

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216878

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216878Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 216878

TOFACITINIB CITRATE

SOLUTION;ORAL; EQ 1MG BASE/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	No	AA	216878	SLAYBACK PHARMA LLC
XELJANZ	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	Yes	AA	213082	PFIZER