Details for New Drug Application (NDA): 091050
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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 091050
Tradename: | ABACAVIR SULFATE |
Applicant: | Strides Pharma |
Ingredient: | abacavir sulfate |
Patents: | 0 |
Pharmacology for NDA: 091050
Mechanism of Action | Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 091050
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABACAVIR SULFATE | abacavir sulfate | TABLET;ORAL | 091050 | ANDA | Strides Pharma Science Limited | 64380-717 | 64380-717-01 | 60 TABLET in 1 BLISTER PACK (64380-717-01) |
ABACAVIR SULFATE | abacavir sulfate | TABLET;ORAL | 091050 | ANDA | Strides Pharma Science Limited | 64380-717 | 64380-717-03 | 60 TABLET in 1 BOTTLE (64380-717-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
Approval Date: | Oct 28, 2016 | TE: | AB | RLD: | No |
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