Drugs@FDA: FDA-Approved Drugs
Company: SPECGX LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE/5ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
08/01/1977 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
07/28/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf | |
07/10/2014 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf | |
10/26/2012 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf | |
07/13/2007 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018012s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf | |
01/12/2005 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr.pdf | |
07/31/2001 | SUPPL-24 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018012s24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018012_s024_PAMELOR CAPSULES.pdf | |
12/23/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/29/1994 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/26/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/13/1989 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/25/1986 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/11/1985 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
05/01/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
07/07/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/25/1981 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/31/1980 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
06/15/1979 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/18/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/29/1978 | SUPPL-1 | Efficacy |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/28/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s031lbl.pdf | |
07/10/2014 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s030lbl.pdf | |
10/26/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf | |
07/13/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018012s27lbl.pdf | |
01/12/2005 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf | |
07/31/2001 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018012s24lbl.pdf |