(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| INDOMETHACIN | SUPPOSITORY;RECTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA LIFE SCIENCES | 1984-08-13 | Yes | DISCN | |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| INDOCIN | INDOMETHACIN | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA LIFE SCIENCES | 1982-01-01 | Yes | DISCN | |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| INDOCIN | INDOMETHACIN | CAPSULE;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA LIFE SCIENCES | 1982-01-01 | Yes | DISCN | |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| ZORVOLEXP | DICLOFENAC | CAPSULE;ORAL | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA | 2013-10-18 | Yes | DISCN | |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| CAPSULE, EXTENDED RELEASE;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZYLA | 1982-02-23 | Yes | DISCN | |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 |