Details for New Drug Application (NDA): 090159
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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 090159
Tradename: | ABACAVIR SULFATE AND LAMIVUDINE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | abacavir sulfate; lamivudine |
Patents: | 0 |
Pharmacology for NDA: 090159
Mechanism of Action | Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 090159
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 090159 | ANDA | Aurobindo Pharma Limited | 65862-335 | 65862-335-10 | 10 BLISTER PACK in 1 CARTON (65862-335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 090159 | ANDA | Aurobindo Pharma Limited | 65862-335 | 65862-335-30 | 1 BOTTLE in 1 CARTON (65862-335-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 600MG BASE;300MG | ||||
Approval Date: | Nov 15, 2018 | TE: | AB | RLD: | No |
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