Details for New Drug Application (NDA): 212663
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NDA 212663 describes ABACAVIR SULFATE AND LAMIVUDINE, which is a drug marketed by Pharmobedient, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, Teva Pharms Usa, and Zydus Pharms, and is included in ten NDAs. It is available from five 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
Summary for 212663
| Tradename: | ABACAVIR SULFATE AND LAMIVUDINE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | abacavir sulfate; lamivudine |
| Patents: | 0 |
Pharmacology for NDA: 212663
| Mechanism of Action | Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 212663
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 212663 | ANDA | Macleods Pharmaceuticals Limited | 33342-440 | 33342-440-07 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-440-07) |
| ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 212663 | ANDA | Macleods Pharmaceuticals Limited | 33342-440 | 33342-440-14 | 5 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 600MG BASE;300MG | ||||
| Approval Date: | Dec 19, 2024 | TE: | RLD: | No | |||||
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