Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021438

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INNOPRAN XL (PROPRANOLOL HYDROCHLORIDE)
80MG
Marketing Status: Prescription
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: INNOPRAN XL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: BX
Application Number: N021438
Product Number: 001
Approval Date: Mar 12, 2003
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INNOPRAN XL (PROPRANOLOL HYDROCHLORIDE)
120MG
Marketing Status: Prescription
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: INNOPRAN XL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: BX
Application Number: N021438
Product Number: 002
Approval Date: Mar 12, 2003
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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