DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 091294
The generic ingredient in ABACAVIR SULFATE 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 091294
Tradename: | ABACAVIR SULFATE |
Applicant: | Mylan Pharms Inc |
Ingredient: | abacavir sulfate |
Patents: | 0 |
Therapeutic Class: | Antivirals |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091294
Ingredient-type | Nucleoside Analog |
Mechanism of Action | Nucleoside Reverse Transcriptase 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 | N | 0378-4105-91 |
ABACAVIR SULFATE | abacavir sulfate | TABLET;ORAL | 091294 | ANDA | Mylan Institutional Inc. | 51079-204 | N | 51079-204-06 |
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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