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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075693

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NDA 075693 describes IPRATROPIUM BROMIDE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb Inc, Landela Pharm, Mylan Speciality Lp, Nephron, Pharmascience Inc, Ritedose Corp, Roxane, Sun Pharma Global, Teva Pharms Usa, Watson Labs, Bausch And Lomb, and West-ward Pharms Int, and is included in twenty-one NDAs. It is available from twenty suppliers. Additional details are available on the IPRATROPIUM BROMIDE profile page.

The generic ingredient in IPRATROPIUM BROMIDE is ipratropium bromide. There are seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.

Summary for 075693

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

Pharmacology for NDA: 075693

Mechanism of ActionCholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 075693

Suppliers and Packaging for NDA: 075693

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 075693 ANDA Mylan Pharmaceuticals, Inc. 0378-7970 0378-7970-91 2 POUCH in 1 CARTON (0378-7970-91) > 30 AMPULE in 1 POUCH (0378-7970-64) > 2.5 mL in 1 AMPULE
IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 075693 ANDA Mylan Pharmaceuticals, Inc. 0378-7970 0378-7970-55 30 POUCH in 1 CARTON (0378-7970-55) > 1 AMPULE in 1 POUCH (0378-7970-31) > 2.5 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.02%
Approval Date:Jan 26, 2001TE:ANRLD:No


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