Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006035
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METHERGINE METHYLERGONOVINE MALEATE 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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

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