Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012329
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISMELIN GUANETHIDINE MONOSULFATE EQ 10MG SULFATE TABLET;ORAL Discontinued None No No
ISMELIN GUANETHIDINE MONOSULFATE EQ 25MG SULFATE TABLET;ORAL Discontinued None 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
07/05/1960 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
10/22/1986 SUPPL-54 Labeling

Label is not available on this site.

05/05/1986 SUPPL-53 Labeling

Label is not available on this site.

05/05/1986 SUPPL-52 Labeling

Label is not available on this site.

03/19/1985 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1986 SUPPL-50 Labeling

Label is not available on this site.

02/02/1981 SUPPL-49 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/12/1980 SUPPL-48 Labeling

Label is not available on this site.

05/08/1980 SUPPL-47 Labeling

Label is not available on this site.

01/24/1980 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/17/1980 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/1979 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/1979 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/1979 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/08/1979 SUPPL-41 Labeling

Label is not available on this site.

01/31/1979 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1979 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1977 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1977 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/02/1976 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/29/1976 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1976 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/19/1976 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1975 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1975 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1975 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/31/1975 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/15/1975 SUPPL-26 Unspecified

Label is not available on this site.

09/26/1975 SUPPL-25 Labeling

Label is not available on this site.

05/15/1975 SUPPL-23 Unspecified

Label is not available on this site.

09/26/1975 SUPPL-22 Labeling

Label is not available on this site.

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