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Last Updated: April 16, 2024

Details for New Drug Application (NDA): 018553

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NDA 018553 describes INDERAL LA, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from two 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. Thirty-nine 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
Ingredient:	propranolol hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018553

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 018553

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents

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	St. Mary's Medical Park Pharmacy	60760-538	60760-538-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-538-30)
INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553	NDA	ANI Pharmaceuticals, Inc.	62559-520	62559-520-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-520-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	160MG
Approval Date:	Apr 19, 1983	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	80MG
Approval Date:	Apr 19, 1983	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Apr 19, 1983	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018553

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

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