Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018593
Company: MT ADAMS
Company: MT ADAMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOPTIN | VERAPAMIL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ISOPTIN | VERAPAMIL HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ISOPTIN | VERAPAMIL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/08/1982 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/14/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/20/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 06/22/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/23/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/28/1987 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/15/1988 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/10/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/10/1984 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/16/1986 | SUPPL-6 | Efficacy-New Indication |
Label is not available on this site. |
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| 12/16/1986 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
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| 07/27/1982 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |