FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic...

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Transcript of FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic...

Page 1: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 2: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 3: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 4: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 5: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 6: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 7: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 8: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 9: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 10: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 11: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 12: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 13: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 14: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 15: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 16: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 17: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 18: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 19: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 20: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 21: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 22: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 23: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 24: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 25: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 26: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 27: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 28: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 29: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 30: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 31: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 32: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 33: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,
Page 34: FDA-2010-P-0549-0001 · 2013. 6. 3. · Lupin, and not Teva, is eligible for 180-day generic exclusivity, pursuant to 21 U.S.C. § 355G)(5)(B)(iv), for lamivudine and zidovudine tablets,