Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022239

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SUMAVEL DOSEPRO (SUMATRIPTAN SUCCINATE)
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: SUMATRIPTAN SUCCINATE
Proprietary Name: SUMAVEL DOSEPRO
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022239
Product Number: 002
Approval Date: Nov 26, 2013
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

SUMAVEL DOSEPRO (SUMATRIPTAN SUCCINATE)
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: SUMATRIPTAN SUCCINATE
Proprietary Name: SUMAVEL DOSEPRO
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022239
Product Number: 001
Approval Date: Jul 15, 2009
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information