Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019614
Company: SOCIETAL CDMO
Company: SOCIETAL CDMO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VERELAN | VERAPAMIL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| VERELAN | VERAPAMIL HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| VERELAN | VERAPAMIL HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| VERELAN | VERAPAMIL HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/29/1990 | 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 |
|---|---|---|---|---|---|
| 10/01/2019 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019614s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019614Orig1s056ltr.pdf | |
| 11/18/2016 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019614s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019614Orig1s053ltr.pdf | |
| 10/09/2014 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019614s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019614Orig1s050ltr.pdf | |
| 11/14/2011 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019614s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019614s049ltr.pdf | |
| 03/30/2010 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019614s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf | |
| 03/30/2010 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf |
| 11/29/2000 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/2000 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/1999 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/15/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 07/14/1998 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/30/1997 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1997 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1995 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/08/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/21/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/30/1994 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/06/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/02/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/02/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/12/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/13/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/06/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/09/1992 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/18/1994 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/05/1994 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/01/2019 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019614s056lbl.pdf | |
| 11/18/2016 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019614s053lbl.pdf | |
| 10/09/2014 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019614s050lbl.pdf | |
| 11/14/2011 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019614s049lbl.pdf | |
| 03/30/2010 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019614s045lbl.pdf |
VERELAN
CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075138 | MYLAN |
| VERELAN | VERAPAMIL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019614 | SOCIETAL CDMO |
CAPSULE, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075138 | MYLAN |
| VERELAN | VERAPAMIL HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019614 | SOCIETAL CDMO |
CAPSULE, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075138 | MYLAN |
| VERELAN | VERAPAMIL HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019614 | SOCIETAL CDMO |