01 1AUROBINDO PHARMA LTD
02 2AUROBINDO PHARMA USA
03 2CIPLA LTD
04 1CIPLA USA INC.
05 2EMCURE PHARMS LTD
06 1LACHMAN CONSULTANT SERVICES , INC.
07 2LAURUS GENERICS INC
08 2LAURUS LABS LTD
09 1LUPIN PHARMS
10 5MACLEODS PHARMS LTD
11 1MICRO LABS LTD
12 1MYLAN LABS LTD
13 1MYLAN PHARMS INC
14 1SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD
15 8VIIV HLTHCARE
01 2FILM;ORAL
02 2TABLET
03 2TABLET, FOR SUSPENSION;ORAL
04 5TABLET; ORAL
05 1TABLET; ORAL SUSPENSION
06 19TABLET;ORAL
01 2DISCN
02 6RX
03 23Blank
01 1ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
02 2DOLUTEGRAVIR
03 1DOLUTEGRAVIR AND LAMIVUDINE
04 1DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE
05 10DOLUTEGRAVIR SODIUM
06 1DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE
07 2DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
08 1DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE
09 1DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
10 3DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
11 1DOVATO
12 1JULUCA
13 3TIVICAY
14 1TIVICAY PD
15 1TRIUMEQ
16 1TRIUMEQ PD
01 8Yes
02 23Blank
RLD :
TE Code :
Brand Name : DOLUTEGRAVIR SODIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date :
Application Number : 208355
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DOLUTEGRAVIR SODIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date :
Application Number : 209658
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Brand Name : DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG; 300MG;300MG
Approval Date :
Application Number : 210787
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DOLUTEGRAVIR SODIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date :
Application Number : 209602
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Brand Name : DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG;300MG;300MG
Approval Date :
Application Number : 209670
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : TIVICAY
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Approval Date : 2013-08-12
Application Number : 204790
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : TIVICAY
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2016-06-09
Application Number : 204790
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : TIVICAY
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2016-06-09
Application Number : 204790
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Brand Name : TRIUMEQ
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 600MG BASE;EQ 50MG BASE;300MG
Approval Date : 2014-08-22
Application Number : 205551
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
Brand Name : JULUCA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE;EQ 25MG BASE
Approval Date : 2017-11-21
Application Number : 210192
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
