Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019684
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCARDIA XL | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| PROCARDIA XL | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| PROCARDIA XL | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/06/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/09/2021 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019684Orig1s033ltr.pdf | |
| 01/09/2015 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019684s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019684Orig1s029ltr.pdf | |
| 06/05/2014 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2014 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019684s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019684Orig1s027ltr.pdf | |
| 07/25/2013 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019684s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019684Orig1s026ltr.pdf | |
| 09/27/2011 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019684s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019684s024ltr.pdf | |
| 10/04/2010 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019684s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019684s023ltr.pdf | |
| 04/05/2000 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/18/1998 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/12/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/21/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/08/1997 | SUPPL-12 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19787-S013_Norvasc.pdf |
| 03/29/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/26/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/04/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/14/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1990 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/13/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/09/2021 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf | |
| 01/09/2015 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019684s029lbl.pdf | |
| 05/06/2014 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019684s027lbl.pdf | |
| 07/25/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019684s026lbl.pdf | |
| 09/27/2011 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019684s024lbl.pdf | |
| 10/04/2010 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019684s023lbl.pdf |
PROCARDIA XL
TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216896 | ALEMBIC |
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216067 | ALKEM LABS LTD |
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210614 | NOVAST LABS |
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 077127 | OSMOTICA PHARM US |
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210838 | SPIL |
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 203126 | TWI PHARMS |
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 075289 | VALEANT PHARMS NORTH |
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210012 | ZYDUS PHARMS |
| PROCARDIA XL | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019684 | PFIZER |
TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216896 | ALEMBIC |
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216067 | ALKEM LABS LTD |
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210614 | NOVAST LABS |
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 077127 | OSMOTICA PHARM US |
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210838 | SPIL |
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 203126 | TWI PHARMS |
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 075289 | VALEANT PHARMS NORTH |
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210012 | ZYDUS PHARMS |
| PROCARDIA XL | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019684 | PFIZER |
TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216896 | ALEMBIC |
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 216067 | ALKEM LABS LTD |
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 212016 | ELITE PHARM SOLUTION |
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210614 | NOVAST LABS |
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 077127 | OSMOTICA PHARM US |
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210838 | SPIL |
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 203126 | TWI PHARMS |
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210012 | ZYDUS PHARMS |
| PROCARDIA XL | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019684 | PFIZER |