General MedicationsORALGeneric

OMECLAMOX-PAK

AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Standard Dose

500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

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- 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CUMBERLAND Submission history Latest submission status date: 2024-05-01 00:00:00.

Structured Monograph

Clinical summary

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- 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CUMBERLAND Submission history Latest submission status date: 2024-05-01 00:00:00.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.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.