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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018553

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INDERAL LA (PROPRANOLOL HYDROCHLORIDE)
60MG
Marketing Status: Prescription
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: INDERAL LA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018553
Product Number: 004
Approval Date: Mar 18, 1987
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INDERAL LA (PROPRANOLOL HYDROCHLORIDE)
80MG
Marketing Status: Prescription
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: INDERAL LA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018553
Product Number: 002
Approval Date: Apr 19, 1983
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INDERAL LA (PROPRANOLOL HYDROCHLORIDE)
120MG
Marketing Status: Prescription
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: INDERAL LA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018553
Product Number: 003
Approval Date: Apr 19, 1983
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INDERAL LA (PROPRANOLOL HYDROCHLORIDE)
160MG
Marketing Status: Prescription
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: INDERAL LA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 160MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N018553
Product Number: 001
Approval Date: Apr 19, 1983
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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