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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079182
Company: STRIDES PHARMA INTL

Products on ANDA 079182

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079182

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2013	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2023	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/27/2023	SUPPL-7	Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/05/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/09/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079182

OMEPRAZOLE AND SODIUM BICARBONATE

FOR SUSPENSION;ORAL; 20MG/PACKET;1.68GM/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	205545	AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	219161	NOVITIUM PHARMA
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	079182	STRIDES PHARMA INTL

FOR SUSPENSION;ORAL; 40MG/PACKET;1.68GM/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	205545	AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	219161	NOVITIUM PHARMA
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	079182	STRIDES PHARMA INTL

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