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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019614

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VERELAN (VERAPAMIL HYDROCHLORIDE)
120MG
Marketing Status: Prescription
Active Ingredient: VERAPAMIL HYDROCHLORIDE
Proprietary Name: VERELAN
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019614
Product Number: 001
Approval Date: May 29, 1990
Applicant Holder Full Name: SOCIETAL CDMO GAINESVILLE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
VERELAN (VERAPAMIL HYDROCHLORIDE)
180MG
Marketing Status: Prescription
Active Ingredient: VERAPAMIL HYDROCHLORIDE
Proprietary Name: VERELAN
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 180MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019614
Product Number: 003
Approval Date: Jan 9, 1992
Applicant Holder Full Name: SOCIETAL CDMO GAINESVILLE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
VERELAN (VERAPAMIL HYDROCHLORIDE)
240MG
Marketing Status: Prescription
Active Ingredient: VERAPAMIL HYDROCHLORIDE
Proprietary Name: VERELAN
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019614
Product Number: 002
Approval Date: May 29, 1990
Applicant Holder Full Name: SOCIETAL CDMO GAINESVILLE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
VERELAN (VERAPAMIL HYDROCHLORIDE)
360MG
Marketing Status: Prescription
Active Ingredient: VERAPAMIL HYDROCHLORIDE
Proprietary Name: VERELAN
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 360MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019614
Product Number: 004
Approval Date: May 10, 1996
Applicant Holder Full Name: SOCIETAL CDMO GAINESVILLE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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