Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075374
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFLORASONE DIACETATE DIFLORASONE DIACETATE 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
04/27/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-374_Diflorasone%20Diacetate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75374ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-374_Diflorasone.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/12/2005 SUPPL-5 Labeling

Label is not available on this site.

10/02/2003 SUPPL-4 Labeling

Label is not available on this site.

08/19/2003 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/27/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-374_Diflorasone%20Diacetate_prntlbl.pdf

DIFLORASONE DIACETATE

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% OINTMENT;TOPICAL Prescription No AB 206572 AKORN
DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% OINTMENT;TOPICAL Prescription No AB 207440 ANDA REPOSITORY
DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% OINTMENT;TOPICAL Prescription No AB 075374 FOUGERA PHARMS
DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% OINTMENT;TOPICAL Prescription No AB 075331 TARO
DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% OINTMENT;TOPICAL Prescription No AB 210753 TELIGENT PHARMA INC

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