Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008303
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APRESOLINE HYDRALAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
APRESOLINE HYDRALAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
APRESOLINE HYDRALAZINE HYDROCHLORIDE 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
APRESOLINE HYDRALAZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
APRESOLINE HYDRALAZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
01/15/1953 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
04/28/1999 SUPPL-71 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/03/1997 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1996 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

02/28/1996 SUPPL-68 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf
07/12/1994 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1993 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1992 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1991 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

06/19/1991 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1989 SUPPL-62 Labeling

Label is not available on this site.

12/22/1986 SUPPL-59 Labeling

Label is not available on this site.

09/13/1985 SUPPL-58 Labeling

Label is not available on this site.

03/19/1985 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1984 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/15/1983 SUPPL-53 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/15/1983 SUPPL-52 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/15/1983 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/23/1982 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

05/05/1982 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/18/1985 SUPPL-47 Labeling

Label is not available on this site.

02/27/1981 SUPPL-46 Labeling

Label is not available on this site.

05/08/1980 SUPPL-45 Labeling

Label is not available on this site.

01/25/1980 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1979 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/02/1979 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/29/1979 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1979 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/09/1979 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/09/1979 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/04/1979 SUPPL-37 Labeling

Label is not available on this site.

10/04/1979 SUPPL-36 Labeling

Label is not available on this site.

09/07/1977 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1977 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/18/1977 SUPPL-31 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/18/1977 SUPPL-29 Labeling

Label is not available on this site.

04/18/1977 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/11/1977 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1976 SUPPL-24 Labeling

Label is not available on this site.

07/11/1977 SUPPL-23 Labeling

Label is not available on this site.

07/11/1977 SUPPL-21

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/1996 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf

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