General MedicationsORALGeneric

FIORINAL W/CODEINE

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Standard Dose

325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 FIORINAL W/CODEINE is listed in Drugs@FDA under application 019429 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE Form and strength CAPSULE;ORAL - 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ALLERGAN Submission history Latest submission status date: 2021-04-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview FIORINAL W/CODEINE is listed in Drugs@FDA under application 019429 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE Form and strength CAPSULE;ORAL - 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ALLERGAN Submission history Latest submission status date: 2021-04-28 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.