Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008708
Company: CONCORDIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIBENZYLINE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription AB Yes Yes
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.

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

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 204522 PAR PHARM INC
PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 201050 WEST-WARD PHARMS INT

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