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Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(ANDA) 091294 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE MYLAN PHARMS INC 2012-06-18 No RX AB
(ANDA) 201570 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE APOTEX INC 2012-12-17 No RX AB
(NDA) 020977 001 ZIAGENP ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE VIIV HLTHCARE 1998-12-17 Yes RX AB
(ANDA) 091560 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE HETERO LABS LTD III 2013-09-13 No RX AB
(ANDA) 091050 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE STRIDES PHARMA 2016-10-28 No RX AB
(NDA) 020978 001 ZIAGENP ABACAVIR SULFATE SOLUTION;ORAL EQ 20MG BASE/ML VIIV HLTHCARE 1998-12-17 Yes RX AA
(ANDA) 077844 001 ABACAVIR SULFATE ABACAVIR SULFATE TABLET;ORAL EQ 300MG BASE AUROBINDO PHARMA LTD 2012-12-17 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
(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
(ANDA) 206151 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG AUROBINDO PHARMA LTD 2017-03-28 No RX AB
(NDA) 021652 001 EPZICOMP ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG VIIV HLTHCARE 2004-08-02 Yes RX AB
(ANDA) 204990 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG LUPIN LTD 2017-03-28 No RX AB
(ANDA) 091144 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG CIPLA LTD 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 RX AB
(NDA) 021205 001 TRIZIVIRP ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE TABLET;ORAL EQ 300MG BASE;150MG;300MG VIIV HLTHCARE 2000-11-14 Yes RX AB
(ANDA) 202912 001 ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE TABLET;ORAL EQ 300MG BASE;150MG;300MG LUPIN LTD 2013-12-05 No RX AB
(NDA) 208743 001 TYMLOSP ABALOPARATIDE SOLUTION;SUBCUTANEOUS 3.12MG/1.56ML (2MG/ML) RADIUS HEALTH INC 2017-04-28 Yes RX
(NDA) 021320 001 PLENAXISP ABARELIX INJECTABLE;INTRAMUSCULAR 100MG/VIAL SPECIALITY EUROPEAN 2003-11-25 No DISCN
(NDA) 202379 001 ZYTIGAP ABIRATERONE ACETATE TABLET;ORAL 250MG JANSSEN BIOTECH 2011-04-28 Yes RX
(NDA) 202379 002 ZYTIGA ABIRATERONE ACETATE TABLET;ORAL 500MG JANSSEN BIOTECH 2017-04-14 Yes RX