Abacavir and Lamivudine

Product NDC

66993-482

11-digit product format

669930482

Labeler code

66993

Product ID

66993-482_ee69959a-8c33-497b-a309-1c4a50a2b127

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

abacavir sulfate and lamivudine

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Prasco Laboratories

Application

NDA021652

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2016-09-29

Marketing end

2020-12-31

Substance

ABACAVIR SULFATE; LAMIVUDINE

Active strength

600 mg/1; mg/1

Pharmacologic classes

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record