General MedicationsINTRAMUSCULAR, ORALGeneric

LUPANETA PACK

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

Standard Dose

11.25MG/VIAL,N/A;N/A,5MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview LUPANETA PACK is listed in Drugs@FDA under application 203696 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient LEUPROLIDE ACETATE; NORETHINDRONE ACETATE Form and strength INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG Sponsor ABBVIE ENDOCRINE Submission history Latest submission status date: 2023-08-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview LUPANETA PACK is listed in Drugs@FDA under application 203696 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient LEUPROLIDE ACETATE; NORETHINDRONE ACETATE Form and strength INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG Sponsor ABBVIE ENDOCRINE Submission history Latest submission status date: 2023-08-09 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.