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Generated: July 20, 2017

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Details for New Drug Application (NDA): 202496

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NDA 202496 describes ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, which is a drug marketed by Apotex Inc, Teva Pharms, Nephron, Cipla Ltd, Watson Labs Teva, Sandoz Inc, and Ritedose Corp, and is included in seven NDAs. It is available from eleven suppliers. Additional details are available on the ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE profile page.

The generic ingredient in ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE 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: 202496

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 202496

Suppliers and Packaging for NDA: 202496

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION 202496 ANDA Mylan Pharmaceuticals, Inc. 0378-9671 0378-9671-30 1 POUCH in 1 CARTON (0378-9671-30) > 30 AMPULE in 1 POUCH (0378-9671-64) > 3 mL in 1 AMPULE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION 202496 ANDA Mylan Pharmaceuticals, Inc. 0378-9671 0378-9671-58 6 POUCH in 1 CARTON (0378-9671-58) > 5 AMPULE in 1 POUCH (0378-9671-98) > 3 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.083% BASE;0.017%
Approval Date:Oct 1, 2012TE:ANRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cipla
Farmers Insurance
Teva
Queensland Health
Accenture
UBS
Daiichi Sankyo
Federal Trade Commission
Express Scripts
Chinese Patent Office

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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