➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Colorcon
McKesson
Merck
Harvard Business School

Last Updated: June 25, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074543


Email this page to a colleague

« Back to Dashboard

NDA 074543 describes ALBUTEROL SULFATE, which is a drug marketed by Cipla, Lupin, Perrigo Pharms Co, Actavis Mid Atlantic, Akorn, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Rx, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Mylan, Aizant, Am Therap, Amneal Pharms Co, Dava Pharms Inc, Eywa, Pliva, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Zydus Pharms, Fosun Pharma, and Watson Labs Teva, and is included in seventy-nine NDAs. It is available from thirty 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-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 074543
Tradename:ALBUTEROL SULFATE
Applicant:Akorn
Ingredient:albuterol sulfate
Patents:0
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 A-S Medication Solutions 50090-0517 50090-0517-0 1 BOTTLE, GLASS in 1 CARTON (50090-0517-0) > 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

Profile for product number 001

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Moodys
McKesson
Baxter
Colorcon

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 verification 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.