Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCARDIA | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| PROCARDIA | NIFEDIPINE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/31/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/09/2015 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018482s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018482Orig1s052ltr.pdf | |
| 07/25/2013 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018482Orig1s051ltr.pdf | |
| 09/27/2011 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018482s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018482s049ltr.pdf | |
| 04/05/2000 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/2002 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18482s43ltr.pdf |
| 08/12/1997 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/21/1997 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 03/22/1996 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1995 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1995 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1994 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 10/04/1995 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 04/04/1994 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1992 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1990 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1988 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/13/1988 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/12/1987 | SUPPL-27 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/03/1987 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/04/1995 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/17/1986 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1985 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/26/1985 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/30/1985 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1985 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/20/1984 | SUPPL-15 | Efficacy |
Label is not available on this site. |
||
| 11/20/1984 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/24/1986 | SUPPL-12 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 03/22/1984 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/24/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/06/1984 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/23/1983 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/1983 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/10/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1983 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/17/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/06/1982 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/09/2015 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018482s052lbl.pdf | |
| 07/25/2013 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf | |
| 09/27/2011 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018482s049lbl.pdf |
PROCARDIA
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 |