Details for New Drug Application (NDA): 201107
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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 201107
Tradename: | ABACAVIR SULFATE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | abacavir sulfate |
Patents: | 0 |
Pharmacology for NDA: 201107
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 201107
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABACAVIR SULFATE | abacavir sulfate | SOLUTION;ORAL | 201107 | ANDA | Camber Pharmaceuticals, Inc. | 31722-562 | 31722-562-24 | 240 mL in 1 BOTTLE (31722-562-24) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/ML | ||||
Approval Date: | Sep 26, 2016 | TE: | AA | RLD: | No |
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