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Last Updated: October 27, 2021

DrugPatentWatch Database Preview

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. There is one patent protecting this drug. 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. Forty-two 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:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021438
Mechanism of ActionAdrenergic beta-Antagonists
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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength80MG
Approval Date:Mar 12, 2003TE:BXRLD:Yes
Patent:⤷  Try it FreePatent Expiration:Oct 4, 2021Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Mar 12, 2003TE:BXRLD:Yes
Patent:⤷  Try it FreePatent Expiration:Oct 4, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021438

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

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