• English
  • 简体中文
Login Register
Current Location: Home > Orange Book Search (FDA) Feedback Help
-
-
-
-
-
Export data
Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(NDA) 017814 001 INDOCIN INDOMETHACIN SUPPOSITORY;RECTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZYLA LIFE SCIENCES 1984-08-13 Yes DISCN
(NDA) 016059 002 INDOCIN INDOMETHACIN CAPSULE;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZYLA LIFE SCIENCES 1982-01-01 Yes DISCN
(NDA) 016059 001 INDOCIN INDOMETHACIN CAPSULE;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZYLA LIFE SCIENCES 1982-01-01 Yes DISCN
(NDA) 204592 001 ZORVOLEXP DICLOFENAC CAPSULE;ORAL 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZYLA 2013-10-18 Yes DISCN
(NDA) 018332 001 INDOCIN INDOMETHACIN SUSPENSION;ORAL 25MG/5ML ZYLA 1985-10-10 Yes RX AB
(NDA) 022382 001 SPRIX KETOROLAC TROMETHAMINE SPRAY, METERED;NASAL 15.75MG/SPRAY ZYLA 2010-05-14 Yes RX
(NDA) 202080 002 OXAYDOP OXYCODONE HYDROCHLORIDE TABLET;ORAL 7.5MG ZYLA 2011-06-17 Yes DISCN
(NDA) 208603 001 ARYMO ERP MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG ZYLA 2017-01-09 Yes DISCN
(NDA) 208603 003 ARYMO ERP MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG ZYLA 2017-01-09 Yes DISCN
(NDA) 018185 001 INDOCIN SR INDOMETHACIN CAPSULE, EXTENDED RELEASE;ORAL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZYLA 1982-02-23 Yes DISCN
(NDA) 204592 002 ZORVOLEXP DICLOFENAC CAPSULE;ORAL 35MG ZYLA 2013-10-18 Yes DISCN
(NDA) 208603 002 ARYMO ERP MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG ZYLA 2017-01-09 Yes DISCN
(NDA) 202080 001 OXAYDOP OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG ZYLA 2011-06-17 Yes DISCN
(ANDA) 078899 001 BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE CAPSULE;ORAL EQ 5MG BASE ZYDUS PHARMS USA INC 2008-07-30 No RX AB
(ANDA) 079017 002 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE ZYDUS PHARMS USA INC 2010-09-16 No RX AB
(ANDA) 079017 006 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE ZYDUS PHARMS USA INC 2010-09-16 No RX AB
(ANDA) 091352 001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 10MG ZYDUS PHARMS USA INC 2012-11-19 No RX AB
(ANDA) 079017 004 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE ZYDUS PHARMS USA INC 2010-09-16 No RX AB
(ANDA) 079017 003 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE ZYDUS PHARMS USA INC 2010-09-16 No RX AB
(ANDA) 079017 005 ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE ZYDUS PHARMS USA INC 2010-09-16 No RX AB