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Details for New Drug Application (NDA): 202912
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 two suppliers. 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 eleven drug master file entries for this compound. Four 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 eleven drug master file entries for this compound. Four 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 |
| Therapeutic Class: | Antivirals |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202912
| Ingredient-type | Nucleoside Analog |
| 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 LIMITED | 57297-286 | E | 57297-286-01 |
| ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE | abacavir sulfate; lamivudine; zidovudine | TABLET;ORAL | 202912 | ANDA | LUPIN LIMITED | 57297-286 | E | 57297-286-02 |
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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