Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074958
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | 75MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 08/26/1997 | 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 |
|---|---|---|---|---|---|
| 09/14/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 06/29/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 08/15/2005 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/14/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 10/11/2002 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/24/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 04/24/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/02/1999 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 12/02/1999 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 02/12/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |