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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205545

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NDA 205545 describes OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Aurolife Pharma Llc, Ajanta Pharma Ltd, Actavis Elizabeth, Par Pharm, Perrigo R And D, Dr Reddys Labs Ltd, and Sciegen Pharms Inc, and is included in eleven NDAs. It is available from sixteen suppliers. Additional details are available on the OMEPRAZOLE AND SODIUM BICARBONATE profile page.

The generic ingredient in OMEPRAZOLE AND SODIUM BICARBONATE is omeprazole; sodium bicarbonate. There are one hundred and twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

Summary for NDA: 205545

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 205545

Suppliers and Packaging for NDA: 205545

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL 205545 ANDA Ajanta Pharma Limited 27241-029 27241-029-31 30 POWDER, FOR SUSPENSION in 1 CARTON (27241-029-31)
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL 205545 ANDA Ajanta Pharma Limited 27241-029 27241-029-62 1 POWDER, FOR SUSPENSION in 1 PACKET (27241-029-62)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength20MG/PACKET;1.68GM/PACKET
Approval Date:Jul 27, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/PACKET;1.68GM/PACKET
Approval Date:Jul 27, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Novartis
Fish and Richardson
UBS
Julphar
Covington
Deloitte
McKinsey
Teva
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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