Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079061
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% 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
06/23/2009 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
04/17/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

ALCLOMETASONE DIPROPIONATE

CREAM;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% CREAM;TOPICAL Prescription No AB 076973 FOUGERA PHARMS
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% CREAM;TOPICAL Prescription No AB 079061 GLENMARK GENERICS
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% CREAM;TOPICAL Prescription No AB 076587 TARO

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