Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074171
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 100MG/60ML ENEMA;RECTAL 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
05/27/1994 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
06/17/2008 SUPPL-23 Labeling

Label is not available on this site.

07/09/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

01/04/2002 SUPPL-11 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/23/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

01/04/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

02/26/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

02/15/2000 SUPPL-7 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/15/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/25/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/20/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

HYDROCORTISONE

ENEMA;RECTAL; 100MG/60ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COLOCORT HYDROCORTISONE 100MG/60ML ENEMA;RECTAL Prescription No AB 075172 PADDOCK LLC
CORTENEMA HYDROCORTISONE 100MG/60ML ENEMA;RECTAL Prescription Yes AB 016199 ANI PHARMS
HYDROCORTISONE HYDROCORTISONE 100MG/60ML ENEMA;RECTAL Prescription No AB 074171 TEVA PHARMS

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