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Details for New Drug Application (NDA): 202912
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NDA 202912 describes ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE profile page.
The generic ingredient in ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
The generic ingredient in ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
Summary for 202912
| Tradename: | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE |
| Applicant: | Lupin Ltd |
| Ingredient: | abacavir sulfate; lamivudine; zidovudine |
| Patents: | 0 |
Pharmacology for NDA: 202912
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 202912
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE | abacavir sulfate; lamivudine; zidovudine | TABLET;ORAL | 202912 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-286 | 68180-286-01 | 1 BOTTLE in 1 CARTON (68180-286-01) > 100 TABLET in 1 BOTTLE |
| ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE | abacavir sulfate; lamivudine; zidovudine | TABLET;ORAL | 202912 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-286 | 68180-286-02 | 1 BOTTLE in 1 CARTON (68180-286-02) > 500 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE;150MG;300MG | ||||
| Approval Date: | Dec 5, 2013 | TE: | AB | RLD: | No | ||||
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