Details for New Drug Application (NDA): 091560
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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 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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