Details for New Drug Application (NDA): 091294
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NDA 091294 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 091294
| Tradename: | ABACAVIR SULFATE |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | abacavir sulfate |
| Patents: | 0 |
Pharmacology for NDA: 091294
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors Cytochrome P450 1A1 Inhibitors |
Suppliers and Packaging for NDA: 091294
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE | abacavir sulfate | TABLET;ORAL | 091294 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4105 | 0378-4105-91 | 1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
| ABACAVIR SULFATE | abacavir sulfate | TABLET;ORAL | 091294 | ANDA | Mylan Institutional Inc. | 51079-204 | 51079-204-06 | 50 BLISTER PACK in 1 CARTON (51079-204-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | Jun 18, 2012 | TE: | AB | RLD: | No | ||||
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