Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072034
Company: AM REGENT
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 5MG/ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/24/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/21/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
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11/05/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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08/14/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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06/13/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
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02/28/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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08/17/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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11/18/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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05/07/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/18/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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06/19/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |