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Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(NDA) 020978 001 ZIAGEN ABACAVIR SULFATE SOLUTION;ORAL EQ 20MG BASE/ML VIIV HLTHCARE 1998-12-17 Yes RX AA
(NDA) 020977 001 ZIAGEN ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE VIIV HLTHCARE 1998-12-17 Yes DISCN
(ANDA) 091294 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE MYLAN PHARMS INC 2012-06-18 No RX AB
(ANDA) 201107 001 ABACAVIR SULFATE ABACAVIR SULFATE SOLUTION;ORAL EQ 20MG BASE/ML HETERO LABS LTD III 2016-09-26 No RX AA
(ANDA) 091560 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE HETERO LABS LTD III 2013-09-13 No RX AB
(ANDA) 077844 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE AUROBINDO PHARMA LTD 2012-12-17 No RX AB
(ANDA) 078119 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE CIPLA 2017-11-21 No RX AB
(ANDA) 091050 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE STRIDES PHARMA 2016-10-28 No RX AB
(ANDA) 077950 001 ABACAVIR SULFATE ABACAVIR SULFATE SOLUTION;ORAL EQ 20MG BASE/ML AUROBINDO PHARMA LTD 2018-03-14 No RX AA
(ANDA) 201570 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE APOTEX INC 2012-12-17 No DISCN
(NDA) 205551 001 TRIUMEQP ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;EQ 50MG BASE;300MG VIIV HLTHCARE 2014-08-22 Yes RX
(NDA) 215413 001 TRIUMEQ PDP ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE TABLET, FOR SUSPENSION;ORAL EQ 60MG BASE;EQ 5MG BASE;30MG VIIV HLTHCARE 2022-03-30 Yes RX
(ANDA) 208990 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG ZYDUS PHARMS 2018-11-15 No DISCN
(ANDA) 206151 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG AUROBINDO PHARMA 2017-03-28 No DISCN
(ANDA) 091144 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG CIPLA 2017-03-28 No RX AB
(ANDA) 079246 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG TEVA PHARMS USA 2016-09-29 No DISCN
(ANDA) 090159 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG AUROBINDO PHARMA LTD 2018-11-15 No RX AB
(ANDA) 216332 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG LAURUS 2022-07-25 No RX AB
(NDA) 204311 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET, FOR SUSPENSION;ORAL EQ 60MG BASE;30MG MYLAN LABS LTD 2023-12-22 Yes DISCN
(ANDA) 204990 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG CHARTWELL RX 2017-03-28 No RX AB