Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078306
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 08/09/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078306ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/26/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/01/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/01/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2010 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/31/2010 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |