← FDA Drug Approvals (Drugs@FDA)

ABACAVIR AND LAMIVUDINE

NDA · New Drug Application · Sponsor: MYLAN LABS LTD · Approved 2014-10-23

Drug application

FDA Application #

NDA204915

Application type

New Drug Application

Brand name

ABACAVIR AND LAMIVUDINE

Generic name

Abacavir

Active ingredients

ABACAVIR; LAMIVUDINE

Dosage form

TABLET

Route

ORAL SUSPENSION

Marketing status

None (Tentative Approval)

Sponsor

MYLAN LABS LTD

First approval

2014-10-23

Source

Authoritative

Drugs@FDA application overview

Machine

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