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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016199
Company: ANI PHARMS

Products on NDA 016199

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORTENEMA	HYDROCORTISONE	100MG/60ML	ENEMA;RECTAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016199

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/12/1966	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2014	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
02/21/2008	SUPPL-35	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016199s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016199s035ltr.pdf
09/25/1996	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
03/22/1995	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
11/29/1994	SUPPL-31	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/12/1992	SUPPL-30	Labeling		Label is not available on this site.
12/28/1993	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
02/12/1992	SUPPL-28	Labeling		Label is not available on this site.
03/24/1992	SUPPL-27	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/04/1984	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
12/19/1979	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
06/19/1978	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/29/1976	SUPPL-16	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/19/1979	SUPPL-15	Labeling		Label is not available on this site.

Labels for NDA 016199

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2008	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016199s035lbl.pdf

Therapeutic Equivalents for NDA 016199

CORTENEMA

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	CHARTWELL
CORTENEMA	HYDROCORTISONE	100MG/60ML	ENEMA;RECTAL	Prescription	Yes	AB	016199	ANI PHARMS

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