General MedicationsORALGeneric
TRI-LO-LINYAH
NORGESTIMATE; ETHINYL ESTRADIOL
Standard Dose
0.25MG; 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 - 0.25MG; 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 - 0.25MG; 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.