Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074439
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Discontinued | None | No | No |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 12/10/1996 | 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 |
|---|---|---|---|---|---|
| 04/12/2007 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/29/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 03/12/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/29/1999 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/26/1999 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/10/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |