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General MedicationsORALGeneric

TRI-LO-LINYAH

NORGESTIMATE; ETHINYL ESTRADIOL

Standard Dose
0.215MG; 0.025MG
Max Dose
Refer to approved labeling
Primary Use
Marketing status: None (Tentative Approval)
Summary

Approval overview TRI-LO-LINYAH is listed in Drugs@FDA under application 090541 (ANDA).

Marketing status: None (Tentative Approval) Active ingredient NORGESTIMATE; ETHINYL ESTRADIOL Form and strength TABLET; ORAL - 0.215MG; 0.025MG Sponsor NOVAST LABS Submission history Latest submission status date: 2022-09-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview TRI-LO-LINYAH is listed in Drugs@FDA under application 090541 (ANDA). Marketing status: None (Tentative Approval) Active ingredient NORGESTIMATE; ETHINYL ESTRADIOL Form and strength TABLET; ORAL - 0.215MG; 0.025MG Sponsor NOVAST LABS Submission history Latest submission status date: 2022-09-02 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.