Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008278
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REGITINE PHENTOLAMINE MESYLATE 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
01/30/1952 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
04/29/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/20/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/09/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1986 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1983 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/27/1983 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/13/1985 SUPPL-11 Labeling

Label is not available on this site.

09/09/1981 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/18/1981 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/07/1980 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/11/1977 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/12/1977 SUPPL-6 Labeling

Label is not available on this site.

02/11/1977 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

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