Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018485
Company: MT ADAMS
Company: MT ADAMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOPTIN | VERAPAMIL HYDROCHLORIDE | 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
08/12/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
12/11/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/07/1994 | SUPPL-9 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/018485s009lbl.pdf | |
09/16/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/08/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
12/18/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/21/1984 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/16/1987 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/12/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/12/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/07/1994 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/018485s009lbl.pdf |