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Generated: September 21, 2017

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 Mova, Vintage, Copley Pharm, Pliva, Apotex Inc, Warner Chilcott, Teva, Ucb Inc, Roxane, Watson Labs, Actavis Mid Atlantic, Sun Pharm Inds, Ritedose Corp, Amneal Pharms, Hi Tech Pharma, Teva Pharms, Am Therap, Bausch And Lomb, Sandoz, Mylan Speclt, G And W Labs Inc, Nephron, Sun Pharma Global, Dava Pharms Inc, Landela Pharm, Watson Labs Inc, Vistapharm, Mylan, Wockhardt Eu Operatn, Cipla Ltd, Watson Labs Teva, and Sandoz Inc, and is included in sixty-five NDAs. It is available from thirty-one 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. Fourteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for NDA: 074454

Tradename:
1
Applicant:
1
Ingredient:
1
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 0472-0825-04 118 mL in 1 BOTTLE (0472-0825-04)
ALBUTEROL SULFATE
albuterol sulfate
SYRUP;ORAL 074454 ANDA Actavis Pharma, Inc. 0472-0825 0472-0825-16 473 mL in 1 BOTTLE (0472-0825-16)

Summary 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 500+ biopharmaceutical companies globally:

Citi
Deloitte
Colorcon
Boehringer Ingelheim
Queensland Health
Chubb
Federal Trade Commission
Chinese Patent Office
Cantor Fitzgerald
Johnson and Johnson

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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