Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087795
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 1% CREAM;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
05/03/1983 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
04/26/2001 SUPPL-22 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/27/2000 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/13/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/28/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/07/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/15/1991 SUPPL-9 Labeling

Label is not available on this site.

07/26/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/12/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/13/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/12/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/12/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

HYDROCORTISONE

CREAM;TOPICAL; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALA-CORT HYDROCORTISONE 1% CREAM;TOPICAL Prescription No AT 080706 CROWN LABS
HYDROCORTISONE HYDROCORTISONE 1% CREAM;TOPICAL Prescription No AT 087795 ACTAVIS MID ATLANTIC
HYDROCORTISONE HYDROCORTISONE 1% CREAM;TOPICAL Prescription No AT 080693 FOUGERA PHARMS INC

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