Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075172
Company: PADDOCK LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLOCORT 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
12/03/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75172ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/23/2008 SUPPL-12 Labeling

Label is not available on this site.

07/27/2001 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/08/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

COLOCORT

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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