Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022256

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SAVELLA (MILNACIPRAN HYDROCHLORIDE)
12.5MG
Marketing Status: Prescription

Active Ingredient: MILNACIPRAN HYDROCHLORIDE
Proprietary Name: SAVELLA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022256
Product Number: 001
Approval Date: Jan 14, 2009
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SAVELLA (MILNACIPRAN HYDROCHLORIDE)
25MG
Marketing Status: Prescription

Active Ingredient: MILNACIPRAN HYDROCHLORIDE
Proprietary Name: SAVELLA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022256
Product Number: 002
Approval Date: Jan 14, 2009
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SAVELLA (MILNACIPRAN HYDROCHLORIDE)
50MG
Marketing Status: Prescription

Active Ingredient: MILNACIPRAN HYDROCHLORIDE
Proprietary Name: SAVELLA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022256
Product Number: 003
Approval Date: Jan 14, 2009
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SAVELLA (MILNACIPRAN HYDROCHLORIDE)
100MG
Marketing Status: Prescription

Active Ingredient: MILNACIPRAN HYDROCHLORIDE
Proprietary Name: SAVELLA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022256
Product Number: 004
Approval Date: Jan 14, 2009
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information