EPZICOM

Product NDC
70518-0691
11-digit product format
705180691
Labeler code
70518
Product ID
70518-0691_8ac4e1be-8d76-a66f-e053-2a95a90a097f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abacavir sulfate and lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA021652
Marketing category
NDA
Marketing start
2017-08-17
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record