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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008708
Company: CONCORDIA

Products on NDA 008708

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIBENZYLINE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008708

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/1953	ORIG-1	Approval	Type 1 - New Molecular Entity	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
04/03/2008	SUPPL-25	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008708s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008708s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/008708Orig1s025.pdf
12/30/2003	SUPPL-23	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08708slr023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/008708Orig1s023.pdf
01/15/2003	SUPPL-22	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08708slr022ltr.pdf
03/30/2001	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
02/03/1995	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/12/1991	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
03/01/1991	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
07/28/1988	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
05/25/1984	SUPPL-16	Labeling		Label is not available on this site.
05/27/1987	SUPPL-15	Labeling		Label is not available on this site.
03/15/1983	SUPPL-12	Labeling		Label is not available on this site.

Labels for NDA 008708

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2008	SUPPL-25	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008708s025lbl.pdf

Therapeutic Equivalents for NDA 008708

DIBENZYLINE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIBENZYLINE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	Yes	AB	008708	CONCORDIA
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	212568	AMNEAL
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	215600	AUROBINDO PHARMA
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	204522	ENDO OPERATIONS
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	215042	NOVITIUM PHARMA
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	204551	RISING

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