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Serving leading biopharmaceutical companies globally:

Fuji
Chubb
Dow
US Army
Teva
Cipla
Daiichi Sankyo
Merck
Queensland Health
Fish and Richardson

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074454

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NDA 074454 describes ALBUTEROL SULFATE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharma Global, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, G And W Labs Inc, Mova, Teva, Vintage, Vistapharm, Mylan, Am Therap, Dava Pharms Inc, Pliva, Sandoz, Sun Pharm Industries, Ucb Inc, Warner Chilcott, Cipla Ltd, Sandoz Inc, and Watson Labs Teva, and is included in sixty-six NDAs. It is available from thirty-five suppliers. Additional details are available on the ALBUTEROL SULFATE profile page.

The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 074454
Tradename:ALBUTEROL SULFATE
Applicant:G And W Labs Inc
Ingredient:albuterol sulfate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074454
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 074454
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074454 ANDA Actavis Pharma, Inc. 0472-0825 0472-0825-16 473 mL in 1 BOTTLE (0472-0825-16)
ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074454 ANDA Actavis Pharma, Inc. 0472-0825 0472-0825-04 118 mL in 1 BOTTLE (0472-0825-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 2MG BASE/5ML
Approval Date:Sep 25, 1995TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Johnson and Johnson
Chubb
US Army
McKinsey
AstraZeneca
Cerilliant
Deloitte

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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