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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, and Dr Reddys Labs Ltd, and is included in nine NDAs. It is available from six 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 thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

Summary for NDA: 205545

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; 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; 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:AARLD:No

Summary for product number 002

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

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