Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076730
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT;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
07/29/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76730ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/26/2011 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

ALCLOMETASONE DIPROPIONATE

OINTMENT;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% OINTMENT;TOPICAL Prescription No AB 076884 FOUGERA PHARMS
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 079227 GLENMARK GENERICS
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 076730 TARO

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