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Generated: November 15, 2018

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Details for New Drug Application (NDA): 021438

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NDA 021438 describes INNOPRAN XL, which is a drug marketed by Ani Pharms Inc and is included in one NDA. It is available from three suppliers. 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-one drug master file entries for this compound. Fifty-three 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 Inc
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 Akrimax Pharmaceuticals, LLC 24090-450 24090-450-77 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24090-450-77)
INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021438 NDA Akrimax Pharmaceuticals, LLC 24090-450 24090-450-85 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24090-450-85)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength80MG
Approval Date:Mar 12, 2003TE:BXRLD:No
Patent:➤ Try a Free TrialPatent 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:No
Patent:➤ Try a Free TrialPatent Expiration:Oct 4, 2021Product Flag?YSubstance Flag?Delist Request?

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