Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089682
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 2.5% 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
03/10/1988 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
12/13/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/2001 SUPPL-18 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/11/2001 SUPPL-17 Labeling

Label is not available on this site.

07/11/2001 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/11/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/26/2001 SUPPL-14 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/29/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-11 Labeling

Label is not available on this site.

11/20/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/21/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/10/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/10/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/10/1994 SUPPL-1 Labeling

Label is not available on this site.

HYDROCORTISONE

CREAM;TOPICAL; 2.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALA-CORT HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 080706 CROWN LABS
ANUSOL HC HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 088250 SALIX PHARMS
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 089682 ACTAVIS MID ATLANTIC
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 089414 FOUGERA PHARMS INC
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 040503 LANNETT CO INC
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 085025 PERRIGO NEW YORK
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 040879 RISING
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 088799 TARO PHARM INDS LTD
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 203810 TELIGENT PHARMA INC

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