Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076973
Company: FOUGERA PHARMS
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/12/2005 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076973ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2015 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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