Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078906
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
09/17/2009 | 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 |
---|---|---|---|---|---|
12/22/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
09/26/2019 | SUPPL-9 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/26/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
04/06/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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04/06/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/07/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
VERAPAMIL HYDROCHLORIDE
TABLET, 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 | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206173 | CADILA PHARMS LTD |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078906 | GLENMARK PHARMS LTD |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075072 | STRIDES PHARMA |