Drugs@FDA: FDA-Approved Drugs
Company: RANBAXY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AVENTYL | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
11/06/1964 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/30/2007 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014685s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014685s028ltr.pdf | |
01/12/2005 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14685s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14685s026ltr.pdf | |
08/23/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
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05/29/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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04/24/1998 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/23/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
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07/08/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
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07/08/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
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05/10/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
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05/10/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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05/10/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
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06/20/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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06/20/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
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02/16/1989 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/09/1987 | SUPPL-12 | Labeling |
Label is not available on this site. |
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06/20/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
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10/25/1985 | SUPPL-10 | Labeling |
Label is not available on this site. |
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10/05/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
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05/24/1984 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1984 | SUPPL-7 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/30/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014685s028lbl.pdf | |
01/12/2005 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14685s026lbl.pdf |