Drugs@FDA: FDA-Approved Drugs
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MAPROTILINE HYDROCHLORIDE | MAPROTILINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
MAPROTILINE HYDROCHLORIDE | MAPROTILINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
MAPROTILINE HYDROCHLORIDE | MAPROTILINE HYDROCHLORIDE | 75MG | 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 |
---|---|---|---|---|---|---|---|
10/03/1988 | 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 |
---|---|---|---|---|---|
07/17/2014 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072285s021lbl.pdf | |
01/16/2008 | SUPPL-17 | Labeling |
Label is not available on this site. |
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01/16/2008 | SUPPL-16 | Labeling |
Label is not available on this site. |
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04/13/2006 | 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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05/07/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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02/26/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/13/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/01/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
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04/01/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/27/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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08/06/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/06/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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08/04/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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01/31/1990 | SUPPL-1 | 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 |
---|---|---|---|---|---|
07/17/2014 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072285s021lbl.pdf |