Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209677
Company: SOLA PHARMS

Products on ANDA 209677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	AB	No	No
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2023	ORIG-2	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209677Orig2s000TAltr.pdf
06/17/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2025	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/07/2025	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209677

TERIFLUNOMIDE

TABLET;ORAL; 14MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUBAGIO	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	Yes	AB	202992	SANOFI AVENTIS US
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209690	ACCORD HLTHCARE
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209572	ALEMBIC
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209638	AUROBINDO PHARMA
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209639	BIOCON PHARMA
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209663	GLENMARK SPECLT
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209598	HETERO LABS LTD V
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209623	MSN
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209555	NATCO
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209710	SANDOZ
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209677	SOLA PHARMS
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209700	TEVA PHARMS USA
TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET;ORAL	Prescription	No	AB	209668	ZYDUS PHARMS

TABLET;ORAL; 7MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUBAGIO	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	Yes	AB	202992	SANOFI AVENTIS US
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209690	ACCORD HLTHCARE
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209572	ALEMBIC
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209638	AUROBINDO PHARMA
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209639	BIOCON PHARMA
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209663	GLENMARK SPECLT
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209598	HETERO LABS LTD V
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209623	MSN
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209555	NATCO
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209710	SANDOZ
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209677	SOLA PHARMS
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209700	TEVA PHARMS USA
TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET;ORAL	Prescription	No	AB	209668	ZYDUS PHARMS