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Details for New Drug Application (NDA): 018240

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NDA 018240 describes TENORMIN, which is a drug marketed by Alvogen Malta and Astrazeneca and is included in two NDAs. It is available from two suppliers. Additional details are available on the TENORMIN profile page.

The generic ingredient in TENORMIN is atenolol. There are thirty-three drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the atenolol profile page.

Summary for NDA: 018240

Tradename:
TENORMIN
Applicant:
Alvogen Malta
Ingredient:
atenolol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018240

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 018240

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TENORMIN
atenolol
TABLET;ORAL 018240 NDA AstraZeneca Pharmaceuticals LP 0310-0101 0310-0101-10 100 TABLET in 1 BOTTLE (0310-0101-10)
TENORMIN
atenolol
TABLET;ORAL 018240 NDA AstraZeneca Pharmaceuticals LP 0310-0105 0310-0105-10 100 TABLET in 1 BOTTLE (0310-0105-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Apr 9, 1990TE:ABRLD:No

Expired Orange Book Patents for NDA: 018240

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta
TENORMIN
atenolol
TABLET;ORAL018240-002Approved Prior to Jan 1, 19823,836,671► subscribe
Alvogen Malta
TENORMIN
atenolol
TABLET;ORAL018240-002Approved Prior to Jan 1, 19823,934,032► subscribe
Alvogen Malta
TENORMIN
atenolol
TABLET;ORAL018240-004Apr 9, 19903,836,671► subscribe
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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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