Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021427

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CYMBALTA (DULOXETINE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: CYMBALTA
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021427
Product Number: 001
Approval Date: Aug 3, 2004
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CYMBALTA (DULOXETINE HYDROCHLORIDE)
EQ 30MG BASE
Marketing Status: Prescription

Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: CYMBALTA
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021427
Product Number: 002
Approval Date: Aug 3, 2004
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CYMBALTA (DULOXETINE HYDROCHLORIDE)
EQ 60MG BASE
Marketing Status: Prescription

Active Ingredient: DULOXETINE HYDROCHLORIDE
Proprietary Name: CYMBALTA
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021427
Product Number: 004
Approval Date: Aug 3, 2004
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information