Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076008

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BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
5MG
Marketing Status: Prescription

Active Ingredient: BUSPIRONE HYDROCHLORIDE
Proprietary Name: BUSPIRONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076008
Product Number: 003
Approval Date: Mar 1, 2002
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
7.5MG
Marketing Status: Prescription

Active Ingredient: BUSPIRONE HYDROCHLORIDE
Proprietary Name: BUSPIRONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076008
Product Number: 002
Approval Date: Jul 8, 2013
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
10MG
Marketing Status: Prescription

Active Ingredient: BUSPIRONE HYDROCHLORIDE
Proprietary Name: BUSPIRONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076008
Product Number: 004
Approval Date: Mar 1, 2002
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
15MG
Marketing Status: Prescription

Active Ingredient: BUSPIRONE HYDROCHLORIDE
Proprietary Name: BUSPIRONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076008
Product Number: 005
Approval Date: Mar 28, 2001
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
30MG
Marketing Status: Prescription

Active Ingredient: BUSPIRONE HYDROCHLORIDE
Proprietary Name: BUSPIRONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076008
Product Number: 001
Approval Date: Jun 28, 2001
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information