Details for New Drug Application (NDA): 091560
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NDA 091560 describes ABACAVIR SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Norvium Bioscience, Aurobindo Pharma, Chartwell Rx, Laurus, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd, and is included in seventeen NDAs. It is available from twelve suppliers. Additional details are available on the ABACAVIR SULFATE profile page.
The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
Summary for 091560
| Tradename: | ABACAVIR SULFATE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | abacavir sulfate |
| Patents: | 0 |
Pharmacology for NDA: 091560
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors Cytochrome P450 1A1 Inhibitors |
Suppliers and Packaging for NDA: 091560
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE | abacavir sulfate | TABLET;ORAL | 091560 | ANDA | Camber Pharmaceuticals, Inc. | 31722-557 | 31722-557-60 | 60 TABLET in 1 BOTTLE (31722-557-60) |
| ABACAVIR SULFATE | abacavir sulfate | TABLET;ORAL | 091560 | ANDA | AvPAK | 50268-049 | 50268-049-12 | 20 BLISTER PACK in 1 BOX (50268-049-12) / 1 TABLET in 1 BLISTER PACK (50268-049-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | Sep 13, 2013 | TE: | AB | RLD: | No | ||||
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