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General MedicationsINTRAMUSCULAR, ORALGeneric

LUPANETA PACK

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

Standard Dose
3.75MG/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 - 3.75MG/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 - 3.75MG/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.