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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 205545


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NDA 205545 describes OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Ajanta Pharma Ltd, Anda Repository, Aurobindo Pharma, Aurolife Pharma Llc, Chartwell Rx, Dr Reddys, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma, Zydus, and Zydus Pharms, and is included in fourteen NDAs. It is available from twenty-two 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 thirty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 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 AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 205545 ANDA Ajanta Pharma USA Inc. 27241-029 27241-029-31 30 FOR SUSPENSION in 1 CARTON (27241-029-31)
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 205545 ANDA Ajanta Pharma USA Inc. 27241-029 27241-029-62 1 FOR SUSPENSION in 1 PACKET (27241-029-62)

Profile for product number 001

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

Profile 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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