General MedicationsORALGeneric

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Standard Dose

325MG; 7.5MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE is listed in Drugs@FDA under application 207113 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 325MG; 7.5MG Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2016-09-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE is listed in Drugs@FDA under application 207113 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 325MG; 7.5MG Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2016-09-27 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.