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Details for New Drug Application (NDA): 204068

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NDA 204068 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, and Dr Reddys Labs Ltd, and is included in ten NDAs. It is available from eight 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 eighteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

Summary for NDA: 204068

Tradename:
OMEPRAZOLE AND SODIUM BICARBONATE
Applicant:
Dr Reddys Labs Ltd
Ingredient:
omeprazole; sodium bicarbonate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204068

Suppliers and Packaging for NDA: 204068

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL 204068 ANDA Dr.Reddy's Laboratories Limited 55111-363 55111-363-01 100 CAPSULE in 1 BOTTLE (55111-363-01)
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
CAPSULE;ORAL 204068 ANDA Dr.Reddy's Laboratories Limited 55111-363 55111-363-05 500 CAPSULE in 1 BOTTLE (55111-363-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG;1.1GM
Approval Date:Jul 15, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG;1.1GM
Approval Date:Jul 15, 2016TE:ABRLD:No


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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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