Details for New Drug Application (NDA): 204990
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NDA 204990 describes ABACAVIR SULFATE AND LAMIVUDINE, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Laurus, Lupin Ltd, Teva Pharms Usa, and Zydus Pharms, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the ABACAVIR SULFATE AND LAMIVUDINE profile page.
The generic ingredient in ABACAVIR SULFATE AND LAMIVUDINE is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
The generic ingredient in ABACAVIR SULFATE AND LAMIVUDINE is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
Summary for 204990
| Tradename: | ABACAVIR SULFATE AND LAMIVUDINE |
| Applicant: | Lupin Ltd |
| Ingredient: | abacavir sulfate; lamivudine |
| Patents: | 0 |
Pharmacology for NDA: 204990
| Mechanism of Action | Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 204990
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 204990 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-288 | 68180-288-06 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-288-06) |
| ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 204990 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-288 | 68180-288-09 | 90 TABLET, FILM COATED in 1 BOTTLE (68180-288-09) |
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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