Details for New Drug Application (NDA): 208990
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The generic ingredient in ABACAVIR SULFATE AND LAMIVUDINE is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
Summary for 208990
Tradename: | ABACAVIR SULFATE AND LAMIVUDINE |
Applicant: | Zydus Pharms |
Ingredient: | abacavir sulfate; lamivudine |
Patents: | 0 |
Pharmacology for NDA: 208990
Mechanism of Action | Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 208990
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 208990 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1049 | 70710-1049-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1049-3) |
ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 208990 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1049 | 70710-1049-9 | 90 TABLET, FILM COATED in 1 BOTTLE (70710-1049-9) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 600MG BASE;300MG | ||||
Approval Date: | Nov 15, 2018 | TE: | RLD: | No |
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