Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086944
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPYRIDAMOLE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/16/1991 | 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 |
|---|---|---|---|---|---|
| 01/12/2024 | SUPPL-41 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/09/2001 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/12/1995 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1992 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 11/20/1989 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 04/16/1991 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-30 | Bioequivalence |
Label is not available on this site. |
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| 11/20/1986 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/03/1986 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/27/1986 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/21/1984 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/20/1982 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/20/1982 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/20/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/10/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |