Drugs@FDA: FDA-Approved Drugs
Company: EDISON THERAPS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHERGINE | METHYLERGONOVINE MALEATE | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| METHERGINE | METHYLERGONOVINE MALEATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/19/1946 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/21/2013 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2012 | SUPPL-78 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006035s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006035s078ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/006035Orig1S078.pdf | |
| 04/26/2007 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/006035s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/006035s07LTRd.pdf | |
| 10/01/2003 | SUPPL-73 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06035slr073ltr.pdf |
| 02/18/2004 | SUPPL-72 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06035slr072ltr.pdf |
| 02/05/2002 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/2002 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/2001 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/14/2000 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1999 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/15/1997 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/27/1997 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 02/21/1996 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 10/17/1995 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1995 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1995 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/07/1994 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/11/1993 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1994 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 07/18/1994 | SUPPL-51 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/22/1995 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 05/28/1991 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 09/06/1990 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1989 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1989 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1989 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1989 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-42 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/06/1987 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 07/06/1987 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/07/1986 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/14/1985 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/18/1985 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1985 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 08/30/1984 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1981 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1981 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1981 | SUPPL-22 | Efficacy |
Label is not available on this site. |
||
| 07/22/1980 | SUPPL-21 | Efficacy |
Label is not available on this site. |
||
| 05/15/1979 | SUPPL-20 | Efficacy |
Label is not available on this site. |
||
| 01/23/1979 | SUPPL-19 | Efficacy |
Label is not available on this site. |
||
| 01/16/1979 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/1977 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/03/1976 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1976 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1975 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1975 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/25/2012 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006035s078lbl.pdf | |
| 04/26/2007 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/006035s075lbl.pdf |
METHERGINE
INJECTABLE;INJECTION; 0.2MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHERGINE | METHYLERGONOVINE MALEATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 006035 | EDISON THERAPS LLC |
| METHYLERGONOVINE MALEATE | METHYLERGONOVINE MALEATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090193 | AM REGENT |
| METHYLERGONOVINE MALEATE | METHYLERGONOVINE MALEATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040889 | BRECKENRIDGE |