Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020404
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVITA TRETINOIN 0.025% CREAM;TOPICAL 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
01/14/1997 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
01/22/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/30/2001 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/31/2000 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/15/1999 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

AVITA

CREAM;TOPICAL; 0.025%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVITA TRETINOIN 0.025% CREAM;TOPICAL Prescription No AB 020404 MYLAN PHARMS INC
RETIN-A TRETINOIN 0.025% CREAM;TOPICAL Prescription Yes AB 019049 VALEANT BERMUDA
TRETINOIN TRETINOIN 0.025% CREAM;TOPICAL Prescription No AB 075264 PERRIGO PHARMA INTL

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