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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
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Covington

Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074543

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NDA 074543 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: 074543

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 074543

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 074543

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION 074543 ANDA Rebel Distributors Corp. 21695-245 21695-245-20 1 BOTTLE, GLASS in 1 CARTON (21695-245-20) > 20 mL in 1 BOTTLE, GLASS
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION 074543 ANDA Hi-Tech Pharmacal Co., Inc. 50383-741 50383-741-20 1 BOTTLE, GLASS in 1 CARTON (50383-741-20) > 20 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.5% BASE
Approval Date:Jan 15, 1998TE:ANRLD:No


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Serving 500+ biopharmaceutical companies globally:

Covington
Chinese Patent Office
QuintilesIMS
US Army
UBS
Boehringer Ingelheim
Harvard Business School
Moodys
Fuji
Argus Health

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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