Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019152
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALAN SR | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| CALAN SR | VERAPAMIL HYDROCHLORIDE | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| CALAN SR | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 12/16/1986 | 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 |
|---|---|---|---|---|---|
| 05/22/2020 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019152Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019152Orig1s045ltr.pdf | |
| 10/28/2019 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019152s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019152Orig1s044ltr.pdf | |
| 09/14/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019152s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019152Orig1s041ltr.pdf | |
| 08/24/2016 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019152s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019152Orig1s039ltr.pdf | |
| 10/28/2013 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019152Orig1s038ltr.pdf | |
| 01/10/2013 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/2011 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019152s035ltr.pdf | |
| 03/31/2010 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019152s033ltr.pdf | |
| 07/01/2009 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019152s032ltr.pdf | |
| 11/26/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19152scs030ltr.pdf |
| 02/14/2001 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/2001 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/14/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2001 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/11/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/05/1993 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/17/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1992 | SUPPL-19 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/04/1992 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/28/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1991 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/19/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1989 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/30/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/15/1989 | SUPPL-9 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 09/22/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/08/1989 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/06/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/30/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1987 | 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 |
|---|---|---|---|---|---|
| 05/22/2020 | SUPPL-45 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019152Orig1s045lbl.pdf | |
| 10/28/2019 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019152s044lbl.pdf | |
| 09/14/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019152s041lbl.pdf | |
| 08/24/2016 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019152s039lbl.pdf | |
| 10/28/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf | |
| 12/01/2011 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf | |
| 03/31/2010 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf | |
| 07/01/2009 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf |