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Serving 500+ biopharmaceutical companies globally:

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Generated: June 22, 2017

DrugPatentWatch Database Preview

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 seven suppliers. Additional details are available on the INDERAL LA profile page.

The generic ingredient in INDERAL LA is propranolol hydrochloride. There are twenty-one drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.

Summary for NDA: 018553

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
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 Blenheim Pharmacal, Inc. 10544-286 10544-286-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10544-286-30)
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 018553 NDA Akrimax Pharmaceuticals, LLC 24090-470 24090-470-88 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24090-470-88)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book 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;ORAL018553-004Mar 18, 19874,138,475► Subscribe
Ani Pharms Inc
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL018553-001Apr 19, 19834,138,475► Subscribe
Ani Pharms Inc
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL018553-003Apr 19, 19834,138,475► Subscribe
Ani Pharms Inc
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL018553-002Apr 19, 19834,138,475► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Julphar
QuintilesIMS
Moodys
Express Scripts
Harvard Business School
Baxter
Chinese Patent Office
Fuji
Accenture
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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