Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202552
Company: IMPAX LABS INC
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 No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/23/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202552Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/11/2017 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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 PHARMS INC
ACITRETIN ACITRETIN 10MG CAPSULE;ORAL Prescription No AB 204633 SIGMAPHARM LABS LLC
SORIATANE ACITRETIN 10MG CAPSULE;ORAL Prescription Yes AB 019821 STIEFEL LABS INC

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 203707 MYLAN PHARMS 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
SORIATANE ACITRETIN 17.5MG CAPSULE;ORAL Prescription Yes AB 019821 STIEFEL LABS INC

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 203707 MYLAN PHARMS 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
SORIATANE ACITRETIN 22.5MG CAPSULE;ORAL Prescription Yes AB 019821 STIEFEL LABS INC

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 PHARMS INC
ACITRETIN ACITRETIN 25MG CAPSULE;ORAL Prescription No AB 204633 SIGMAPHARM LABS LLC
SORIATANE ACITRETIN 25MG CAPSULE;ORAL Prescription Yes AB 019821 STIEFEL LABS INC

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