Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071881
Company: HERITAGE
Company: HERITAGE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | AB | No | Yes |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | AB | No | No |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/05/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/17/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
11/17/2017 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
04/18/2016 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
11/29/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
07/29/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
10/14/2015 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/071881Orig1s005ltr.pdf |
01/10/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
06/19/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |
VERAPAMIL HYDROCHLORIDE
TABLET;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 | TABLET;ORAL | Prescription | No | AB | 071881 | HERITAGE |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 070994 | WATSON LABS |
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 071881 | HERITAGE |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 072924 | WATSON LABS |
TABLET;ORAL; 80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 071881 | HERITAGE |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070995 | WATSON LABS |