Drugs@FDA: FDA-Approved Drugs
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOFRANIL-PM | IMIPRAMINE PAMOATE | EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| TOFRANIL-PM | IMIPRAMINE PAMOATE | EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| TOFRANIL-PM | IMIPRAMINE PAMOATE | EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| TOFRANIL-PM | IMIPRAMINE PAMOATE | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/11/1973 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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-78 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf | |
| 07/10/2014 | SUPPL-77 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf | |
| 10/26/2012 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf | |
| 07/13/2007 | SUPPL-74 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf | |
| 01/12/2005 | SUPPL-70 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17090s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17090s070ltr.pdf | |
| 03/26/2004 | SUPPL-69 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17090slr069ltr.pdf |
| 06/20/2002 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/2002 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 06/21/2000 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/2000 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-64 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/31/1997 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 02/19/1993 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1992 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 08/02/1991 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/25/1989 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1989 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1989 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/12/1987 | SUPPL-51 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 05/20/1986 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/1985 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 05/05/1985 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1985 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 10/29/1984 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1984 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 11/05/1984 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1983 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/1986 | SUPPL-41 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/04/1981 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 04/16/1980 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1980 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/30/1980 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/07/1979 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/07/1979 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1979 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/28/1979 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/02/1979 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 06/07/1977 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1975 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1974 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1974 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1974 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1974 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1974 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1974 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1974 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/22/1974 | SUPPL-10 | Unspecified |
Label is not available on this site. |
||
| 05/22/1974 | SUPPL-9 | Unspecified |
Label is not available on this site. |
||
| 05/22/1974 | SUPPL-8 | Unspecified |
Label is not available on this site. |
||
| 05/22/1974 | SUPPL-7 | Unspecified |
Label is not available on this site. |
||
| 05/22/1974 | SUPPL-6 | Unspecified |
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-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf | |
| 07/10/2014 | SUPPL-77 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf | |
| 10/26/2012 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf | |
| 07/13/2007 | SUPPL-74 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf | |
| 01/12/2005 | SUPPL-70 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17090s070lbl.pdf |