Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 006035

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METHERGINE (METHYLERGONOVINE MALEATE)
0.2MG/ML
Marketing Status: Prescription

Active Ingredient: METHYLERGONOVINE MALEATE
Proprietary Name: METHERGINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.2MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N006035
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: EDISON THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

METHERGINE (METHYLERGONOVINE MALEATE)
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: METHYLERGONOVINE MALEATE
Proprietary Name: METHERGINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N006035
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: EDISON THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information