Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074234
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 07/26/1993 | 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 |
|---|---|---|---|---|---|
| 10/19/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/02/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/05/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/23/2002 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/24/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/12/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/20/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/20/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/20/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 06/28/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |