Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202897
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACITRETIN ACITRETIN 17.5MG CAPSULE;ORAL Prescription AB No No
ACITRETIN ACITRETIN 22.5MG 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
04/04/2013 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
07/20/2015 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/20/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/20/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/20/2015 SUPPL-2 Labeling

Label is not available on this site.

ACITRETIN

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
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 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English