General MedicationsORAL SUSPENSIONGeneric
ABACAVIR AND LAMIVUDINE
ABACAVIR;LAMIVUDINE
Standard Dose
120MG;60MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview ABACAVIR AND LAMIVUDINE is listed in Drugs@FDA under application 204915 (NDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ABACAVIR;LAMIVUDINE Form and strength TABLET; ORAL SUSPENSION - 120MG;60MG Sponsor MYLAN LABS LTD Submission history Latest submission status date: 2014-10-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview ABACAVIR AND LAMIVUDINE is listed in Drugs@FDA under application 204915 (NDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ABACAVIR;LAMIVUDINE Form and strength TABLET; ORAL SUSPENSION - 120MG;60MG Sponsor MYLAN LABS LTD Submission history Latest submission status date: 2014-10-23 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.