Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074992
Company: MYLAN TECHNOLOGIES
Company: MYLAN TECHNOLOGIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.6MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
NITROGLYCERIN | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | 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 |
---|---|---|---|---|---|---|---|
11/12/1999 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74992_Nitroglycerine.pdf |