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List of (ANDA’s) filed with USFDA

S No.Application detailsFiled DateANDA#Approved Date
1Hydroxyzine Hydrochloride Tablets, 10 mg,25 mg and 50 mg18-08-200640-80529-05-2008
2Nevirapine Tablets USP, 200 mg02-11-200678-58422-05-2012
3Lamivudine Tablets, 150 mg and 300 mg15-02-200778-85029-01-2008
4Efavirenz Tablets 600 mg16-03-200778-88628-02-2008
5Stavudine capsules USP 15mg, 20 mg, 30 mg and 40 mg31-03-200778-95729-12-2008
6Hydralazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg and 100mg05-07-200740-90112-09-2008
7Zidovudine + Lamivudine Tablets USP, 300 mg/150 mg07-07-200779-12425-04-2008
17-09-2015
8Torsemide Tablets, 5 mg, 10 mg, 20 mg and 100 mg19-09-200779-23428-01-2009
9Zidovudine Tablets USP, 300 mg16-10-200790-09225-04-2008
10Finasteride Tablets USP, 1 mg03-10-200790-06007-06-2010
01-07-2013
11Finasteride Tablets USP, 5 mg03-10-200790-06107-06-2010
12Methocarbamol Tablets USP, 500 mg and 750 mg11-12-200790-20006-11-2010
13Zidovudine + Lamivudine Tablets USP, 300 mg/150 mg copacked with Nevirapine Tablets 200 mg18-02-200822-35607-05-2009
14Levetiracetam Tablets 250 mg, 500 mg, 750 mg and 1000 mg25-03-200890-51508-10-2010
15Tenofovir Tablets 300 mg23-05-200890-63602-04-2010
16Lithium Carbonate Capsules USP 150 mg, 300 mg and 600 mg11-06-200890-70225-09-2009
17Tenofovir and Lamivudine Tablets 300 mg/ 300 mg25-09-200822-45906-11-2009
18Lamivudine and Stavudine Tablets 150 mg/30 mg17-11-200822-47917-05-2010
19Indomethacin Capsules 25 mg and 50 mg10-12-200891-24012-04-2011
20Levocetirizine HCl Tablets 5 mg31-12-200891-26429-06-2012
21Lamivudine Oral Solution 10 mg/ ml30-03-200991-47529-05-2012
22Abacavir Tablets 300 mg19-05-200991-56029-09-2010
14-09-2013
23Lopinavir and Ritonavir Tablets, 200 mg/ 50 mg & 100/25 mg03-07-20099167723-05-2012
24Stavudine, Lamivudine and Nevirapine Tablets, 30/150/200 mg07-08-200920024411-09-2010
25Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200/300 mg20-04-201020180623-12-2011
26Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg01-10-200920089525-11-2014
27Abacavir Oral Solution, 20 mg/mL02-01-201020110702-07-2012
28Citalopram Hydrobromide Oral Solution 10 mg / 5mL25-02-201020145015-12-2015
29Darunavir Tablets 400 mg and 600 mg16-06-201020208307-10-2014
30Indomethacin ER Capsules 75 mg02-07-201020180728-09-2012
31Lamivudine, Zidovudine and Nevirapine Tablets 150/300/200 mg31-08-201020215718-11-2011
32Escitalopram oxalate oral solution 5 mg/5 mL16-09-201020222112-06-2012
33Esomeprazole Capsules 20 mg and 40 mg11-02-201120278421-09-2015
34Levetiracetam Oral Solution 100 mg/mL04-05-201120305228-02-2013
35Maraviroc Tablets 150 mg/300 mg08-08-201120334728-10-2014
36Raltegravir Tablets 400 mg12-09-201120354030-09-2014
37Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 / 300/300 mg10-05-201220411909-11-2012
38Duloxetine HCl DR Capsules, 20 mg, 30 mg, 60 mg25-05-201220434303-08-2016
39Fenofibrate Tablets 48 mg and 145 mg18-09-201220459812-07-2016
40Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 300 mg/300 mg co-packed with Nevirapine Tablets USP, 200 mg18-05-201320535514-03-2014
41Famciclovir Tablets, 125 mg, 250 mg and 500 mg11-12-201020243810-09-2014
42Sildenafil Citrate Tablets, 25 mg, 50 mg and 100 mg24-12-201020265908-11-2013
43Atomoxetine Capsules USP 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg28-12-201020268231-08-2015
44Levofloxacin Tablets, 250 mg, 500 mg and 750 mg27-01-201120280108-01-2015
45Pantoprazole Tablets USP, 20 mg and 40 mg04-03-201120288210-09-2014
46Terbinafine hydrochloride BP equivalent to Terbinafine 250 mg04-03-201120288210-09-2014
47Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg18-03-201120291027-09-2012
48Valacyclovir Hydrochloride Tablets, 500 mg and 1000 mg28-03-201120304708-04-2015
49Donepezil Hydrochloride Tablets, 5 mg and 10 mg18-04-201120303402-02-2015
50Efavirenz, Emitracitabine and Tenofovir DF Tablets 600 mg/200 mg/300 mg14-06-201120305330-10-2013
51Lamivudine Tablets 150 mg/300 mg11-07-201120327706-01-2014
52Lamivudine Tablets 100 mg15-07-201120326002-01-2014
53Lamivudine and Zidovudine Tablets USP 150 mg/ 300 mg18-07-201120325903-02-2014
54Valsartan Tablets 40/80/160/320 mg24-08-201120331105-01-2015
55Sildenafil Citrate Tablets 20 mg07-11-201120362327-11-2014
56Losartan Potassium Tablets 25 mg, 50 mg & 100 mg15-12-201120383512-08-2015
57Acyclovir Tablets 400 mg & 800 mg19-01-201220383429-10-2013
58Montelukast Sodium Chewable Tablets 4 mg & 5 mg07-03-201220409322-05-2015
59Fexofenadine HCl Tablets USP 30 mg, 60 mg and 180 mg27-02-201220409719-08-2016
60Linezolid Tablets 600 mg16-05-201220423906-04-2015
21-12-2015
61Valganciclovir Tablets USP 450 mg09-01-201320516618-03-2016
62Aripiprazole Tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg01-02-201320506428-04-2015
63Abacavir and Lamivudine Tablets 600/300 mg27-02-201320541225-09-2014
64Entecavir Tablets 0.5 mg & 1 mg22-07-201320574021-08-2015
65Tetrabenazine Tablets 12.5 mg and 25 mg16-08-201320457403-02-2016
66Telmisartan Tablets USP 20 mg, 40 mg and 80 mg27-09-201320590122-04-2016
67Abacavir and Lamivudine Tablets 60/30 mg16-01-201520736914-11-2015
68Eltrombopag Tablets 12.5 mg, 25 mg, 50 mg and 75 mg06-01-201420678806-07-2016

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