Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017895
Company: ABBOTT
Company: ABBOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JANIMINE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| JANIMINE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| JANIMINE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 11/15/1974 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | 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 |
|---|---|---|---|---|---|
| 09/12/1988 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1987 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 12/13/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 03/27/1984 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/20/1983 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 07/15/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/25/1981 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/08/1977 | SUPPL-4 | Labeling |
Label is not available on this site. |