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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 021438

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NDA 021438 describes INNOPRAN XL, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the INNOPRAN XL profile page.

The generic ingredient in INNOPRAN XL 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 021438

Tradename:	INNOPRAN XL
Applicant:	Ani Pharms
Ingredient:	propranolol hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021438

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 021438

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

Suppliers and Packaging for NDA: 021438

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438	NDA	ANI Pharmaceuticals, Inc.	62559-590	62559-590-14	14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-590-14)
INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438	NDA	ANI Pharmaceuticals, Inc.	62559-590	62559-590-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-590-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	80MG
Approval Date:	Mar 12, 2003	TE:	BX	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Mar 12, 2003	TE:	BX	RLD:	Yes

Expired US Patents for NDA 021438

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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