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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204582

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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: A204582
Product Number: 001
Approval Date: Sep 18, 2015
Applicant Holder Full Name: HERITAGE PHARMA LABS 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: A204582
Product Number: 002
Approval Date: Sep 18, 2015
Applicant Holder Full Name: HERITAGE PHARMA LABS 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: A204582
Product Number: 003
Approval Date: Sep 18, 2015
Applicant Holder Full Name: HERITAGE PHARMA LABS 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: A204582
Product Number: 004
Approval Date: Sep 18, 2015
Applicant Holder Full Name: HERITAGE PHARMA LABS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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