Details for New Drug Application (NDA): 091294
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The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. One supplier is 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 |
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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