An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 218900
Company: SAPTALIS PHARMS

Products on ANDA 218900

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 218900

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218900

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	219370	AUSON
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	No	AA	216878	HIKMA
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	No	AA	217298	MSN
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	No	AA	218900	SAPTALIS PHARMS
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	No	AA	218407	SUN PHARM INDS INC
XELJANZ	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	Yes	AA	213082	PFIZER

Top