Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/28/1989 | 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 |
|---|---|---|---|---|---|
| 04/12/2016 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2014 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 12/13/2011 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/04/2004 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/06/2003 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/2002 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/22/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/2000 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/09/1998 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/01/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/22/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/18/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/14/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/24/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/11/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/18/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
NIFEDIPINE
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 072781 | ACELLA |
| NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 072579 | ACTAVIS ELIZABETH |
| NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 202644 | HERITAGE PHARMA |
| NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 073250 | LEADING |
| PROCARDIA | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 018482 | PFIZER |