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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217774
Company: ALEMBIC

Products on ANDA 217774

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	25MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217774

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217774

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	217774	ALEMBIC
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	217774	ALEMBIC
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; 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	217774	ALEMBIC
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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