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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204633
Company: SIGMAPHARM LABS LLC

Products on ANDA 204633

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	AB	No	No
ACITRETIN	ACITRETIN	17.5MG	CAPSULE;ORAL	Prescription	AB	No	No
ACITRETIN	ACITRETIN	22.5MG	CAPSULE;ORAL	Prescription	AB	No	No
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204633

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2018	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/06/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204633

ACITRETIN

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	No	AB	091455	BARR LABS INC
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	No	AB	202552	IMPAX LABS INC
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	No	AB	202148	MYLAN
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	No	AB	204633	SIGMAPHARM LABS LLC

CAPSULE;ORAL; 17.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACITRETIN	ACITRETIN	17.5MG	CAPSULE;ORAL	Prescription	No	AB	202552	IMPAX LABS INC
ACITRETIN	ACITRETIN	17.5MG	CAPSULE;ORAL	Prescription	No	AB	204633	SIGMAPHARM LABS LLC
ACITRETIN	ACITRETIN	17.5MG	CAPSULE;ORAL	Prescription	No	AB	202897	TEVA PHARMS USA

CAPSULE;ORAL; 22.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACITRETIN	ACITRETIN	22.5MG	CAPSULE;ORAL	Prescription	No	AB	202552	IMPAX LABS INC
ACITRETIN	ACITRETIN	22.5MG	CAPSULE;ORAL	Prescription	No	AB	204633	SIGMAPHARM LABS LLC
ACITRETIN	ACITRETIN	22.5MG	CAPSULE;ORAL	Prescription	No	AB	202897	TEVA PHARMS USA

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	No	AB	091455	BARR LABS INC
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	No	AB	202552	IMPAX LABS INC
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	No	AB	202148	MYLAN
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	No	AB	204633	SIGMAPHARM LABS LLC

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