Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020144
Company: NOVARTIS
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TRANSDERM-NITRO | NITROGLYCERIN | 0.1MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
TRANSDERM-NITRO | NITROGLYCERIN | 0.2MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
TRANSDERM-NITRO | NITROGLYCERIN | 0.4MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
TRANSDERM-NITRO | NITROGLYCERIN | 0.6MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |
TRANSDERM-NITRO | NITROGLYCERIN | 0.8MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |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. |
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02/03/1999 | SUPPL-18 | Labeling |
Label is not available on this site. |
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10/15/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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10/23/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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12/10/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1996 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1996 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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02/27/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1996 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |