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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020144
Company: NOVARTIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANSDERM-NITRO NITROGLYCERIN 0.1MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
TRANSDERM-NITRO NITROGLYCERIN 0.2MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
TRANSDERM-NITRO NITROGLYCERIN 0.4MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
TRANSDERM-NITRO NITROGLYCERIN 0.6MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No
TRANSDERM-NITRO NITROGLYCERIN 0.8MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No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
10/19/1981 ORIG-1 Approval UNKNOWN

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2000 SUPPL-19 Labeling

Label is not available on this site.
02/03/1999 SUPPL-18 Labeling

Label is not available on this site.
10/15/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
10/23/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
12/10/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
02/27/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
02/27/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
02/27/1996 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
02/27/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
02/27/1996 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.
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