Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086257
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription AT 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
07/24/1978 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
04/29/1993 SUPPL-25 Labeling

Label is not available on this site.

10/19/1992 SUPPL-24 Labeling

Label is not available on this site.

04/16/1991 SUPPL-23 Labeling

Label is not available on this site.

11/21/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/21/1989 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/07/1989 SUPPL-20 Labeling

Label is not available on this site.

04/11/1988 SUPPL-18 Labeling

Label is not available on this site.

07/24/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/08/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/26/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/03/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/24/1982 SUPPL-6 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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