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Last Updated: August 19, 2022

Details for New Drug Application (NDA): 201107

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NDA 201107 describes ABACAVIR SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, Teva Pharms Usa, and Zydus Pharms, and is included in fifteen NDAs. It is available from twelve suppliers. Additional details are available on the ABACAVIR SULFATE profile page.

The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
Summary for 201107
Applicant:Hetero Labs Ltd Iii
Ingredient:abacavir sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 201107
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 Pharmaceutical Associates, Inc. 0121-0897 0121-0897-20 10 TRAY in 1 CASE (0121-0897-20) > 10 CUP, UNIT-DOSE in 1 TRAY > 1 mL in 1 CUP, UNIT-DOSE (0121-0897-15)
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:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/ML
Approval Date:Sep 26, 2016TE:AARLD:No

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