← FDA Drug Approvals (Drugs@FDA)

ABACAVIR SULFATE; LAMIVUDINE

NDA · New Drug Application · Sponsor: MYLAN LABS · Approved 2012-01-31

Drug application

FDA Application #

NDA202381

Application type

New Drug Application

Brand name

ABACAVIR SULFATE; LAMIVUDINE

Generic name

Abacavir Sulfate

Active ingredients

ABACAVIR SULFATE; LAMIVUDINE

Dosage form

TABLET

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

MYLAN LABS

First approval

2012-01-31

Source

Authoritative

Drugs@FDA application overview

Machine

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