Details for New Drug Application (NDA): 091144
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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 091144
Tradename: | ABACAVIR SULFATE AND LAMIVUDINE |
Applicant: | Cipla |
Ingredient: | abacavir sulfate; lamivudine |
Patents: | 0 |
Pharmacology for NDA: 091144
Mechanism of Action | Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 091144
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 091144 | ANDA | Cipla USA Inc. | 69097-362 | 69097-362-02 | 30 TABLET, FILM COATED in 1 BOTTLE (69097-362-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 600MG BASE;300MG | ||||
Approval Date: | Mar 28, 2017 | TE: | AB | RLD: | No |
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