General MedicationsORALGeneric

OXYCODONE AND ASPIRIN

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

Standard Dose

325MG;4.5MG;0.38MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview OXYCODONE AND ASPIRIN is listed in Drugs@FDA under application 087794 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE Form and strength TABLET;ORAL - 325MG;4.5MG;0.38MG Sponsor SUN PHARM INDUSTRIES Submission history Latest submission status date: 2025-03-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview OXYCODONE AND ASPIRIN is listed in Drugs@FDA under application 087794 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE Form and strength TABLET;ORAL - 325MG;4.5MG;0.38MG Sponsor SUN PHARM INDUSTRIES Submission history Latest submission status date: 2025-03-07 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.