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Last Updated: November 17, 2019

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Details for New Drug Application (NDA): 018553

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NDA 018553 describes INDERAL LA, which is a drug marketed by Ani Pharms Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the INDERAL LA profile page.

The generic ingredient in INDERAL LA is propranolol hydrochloride. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.
Summary for 018553
Tradename:INDERAL LA
Applicant:Ani Pharms Inc
Ingredient:propranolol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018553
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 018553
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA AUTHORIZED GENERIC Direct Rx 61919-488 61919-488-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (61919-488-30)
INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA AUTHORIZED GENERIC Direct Rx 61919-489 61919-489-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (61919-489-30)
Paragraph IV (Patent) Challenges for 018553
Tradename Dosage Ingredient NDA Submissiondate
INDERAL LA CAPSULE, EXTENDED RELEASE;ORAL propranolol hydrochloride 018553

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength160MG
Approval Date:Apr 19, 1983TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength80MG
Approval Date:Apr 19, 1983TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Apr 19, 1983TE:ABRLD:Yes

Expired US Patents for NDA 018553

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-004 Mar 18, 1987   Start Trial   Start Trial
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-001 Apr 19, 1983   Start Trial   Start Trial
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-003 Apr 19, 1983   Start Trial   Start Trial
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-002 Apr 19, 1983   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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