Drug Index

OMECLAMOX-PAK

Generic: AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Review priority: STANDARD Marketing status: Discontinued

Route: ORAL
Class: General Medications
Safety profile: generic
Latest regulatory update: 01 May 2024, 12:00 am (UTC)

Structured Monograph

Approval overview OMECLAMOX-PAK is listed in Drugs@FDA under application 050824 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE Form and strength CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CUMBERLAND Submission history Latest submission status date: 2024-05-01 00:00:00. Submission type: SUPPL.