Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080692
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription AT 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
04/16/1975 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
03/07/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/08/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/07/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/26/1984 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/13/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/13/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/13/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/13/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/13/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/13/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

HYDROCORTISONE

OINTMENT;TOPICAL; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription No AT 087796 ACTAVIS MID ATLANTIC
HYDROCORTISONE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription No AT 080692 FOUGERA PHARMS
HYDROCORTISONE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription No AT 086257 TARO
HYDROCORTISONE IN ABSORBASE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription No AT 088138 CMP PHARMA INC

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