BELSOMRA
suvorexant
MERCK
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1039284 | 1039284 | Merck Teknika LLC | 1 | N | 2026-01-01 | 100 Rodolphe Street Building 1300 Durham NC US 27712 |
| 8020892 | 1000532580 | Merck Millipore Ltd. | 1 | N | 2026-01-01 | TULLAGREEN CARRIGTWOHILL COUNTY CORK Munster IE -- |
| 1036761 | 1036761 | Merck Sharp & Dohme Corp. | 1 | N | 2020-04-25 | 4633 Merck Road Wilson NC US 27893 |
| 2510592 | 2510592 | Merck Sharp & Dohme Corp. | 1 | N | 2020-04-25 | 770 Sumneytown Pike West Point PA US 19486 |
| 3003581732 | 3003581732 | MERCK SERONO S.P.A. | 1 | N | 2020-04-25 | Via delle Magnolie, 15 (Loc. Frazione Zona Industriale) Modugno Bari IT 70026 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 1167 | 1721577959 | K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | BSN | 1997-06-10 |
| 1167 | 1352837897 | K934069 | MILLEX, DUALEX (PLUS, ULTRA) | FIB | 1994-04-21 |
| 1167 | 1184990650 | K770703 | FILTER UNIT, SINGLE USE | FPB | 1977-06-14 |
| 234972 | 1941842862 | K152050 | Pencylcap | FMI | 2016-03-02 |
| 1167 | 1795472862 | K143583 | Cathivex ¿GV filter units | FPB | 2015-08-11 |
| 1167 | 1713639829 | K133004 | VENTED MILLEX -GV, CATHIVEX -GV | BSN | 2014-03-27 |
| 1167 | 1590717818 | K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | BSN | 2003-01-17 |
| 1167 | 1407880360 | K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | BSN | 2002-04-04 |
| 214466 | 1557754160 | ||||
| 214469 | 1569025799 | ||||
| 214466 | 1760870776 | ||||
| 214466 | 1805971853 | ||||
| 214466 | 1821649854 | ||||
| 214466 | 1952856850 | ||||
| 214466 | 2025874218 | ||||
| 214467 | 2025874218 | ||||
| 1167 | 1333907169 | ||||
| 1167 | 1495245060 | ||||
| 1167 | 1689998872 | ||||
| 214469 | 1872873194 |
Product Codes Associated With Registrations#
NDC#
STROMECTOL
ivermectin
BELSOMRA
suvorexant
JANUMET
sitagliptin and metformin hydrochloride
JANUMET
sitagliptin and metformin hydrochloride
JANUMET
sitagliptin and metformin hydrochloride
JANUVIA
sitagliptin
JANUVIA
sitagliptin
ISENTRESS
RALTEGRAVIR
JANUVIA
sitagliptin
BELSOMRA
suvorexant
BELSOMRA
suvorexant
EMEND
aprepitant
EMEND
aprepitant
EMEND
aprepitant
ISENTRESS
RALTEGRAVIR
ISENTRESS
RALTEGRAVIR
ZOLINZA
vorinostat
JANUMET
SITAGLIPTIN and METFORMIN HYDROCHLORIDE
JANUMET
SITAGLIPTIN and METFORMIN HYDROCHLORIDE
ZINPLAVA
bezlotoxumab
KEYTRUDA
pembrolizumab
EMEND
FOSAPREPITANT DIMEGLUMINE
EMEND
aprepitant
PIFELTRO
doravirine
ZEPATIER
elbasvir and grazoprevir
PREVYMIS
LETERMOVIR
PREVYMIS
LETERMOVIR
ISENTRESS
RALTEGRAVIR
KEYTRUDA QLEX
pembrolizumab and berahyaluronidase alfa-pmph
PRIMAXIN
imipenem and cilastatin sodium
ISENTRESS
RALTEGRAVIR
CANCIDAS
CASPOFUNGIN ACETATE
CANCIDAS
CASPOFUNGIN ACETATE
INVANZ
ertapenem sodium
RECARBRIO
imipenem anhydrous, cilastatin, and relebactam anhydrous
EMEND
aprepitant
GARDASIL
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
RECOMBIVAX HB
Hepatitis B Vaccine (Recombinant)
PMN#
Cathivex ¿GV Filter Units
MERCK MILLIPORE LTD.
VENTED MILLEX -GV, CATHIVEX -GV
MERCK MILLIPORE LTD.
PALAMED BONE CEMENT
MERCK BIOMATERIAL GMBH
MODIFIED IMIPENEM SUSCEPTIBILITY POWDER
MERCK, SHARP & DOHME
NORFLOXACIN SUSCEPTIBILITY POWDER
MERCK, SHARP & DOHME
IMIPENEM SUSCEPTIBILITY POWDER
MERCK, SHARP & DOHME
LIGHTCAST II CARBIDE BLADE
MERCK, SHARP & DOHME
Applications#
GUDID#
Dualex Transducer Protector - SLGVS25XS
2016-09-01
Hydromillex - SLST025DM
2016-09-01
Dualex Ultra Transducer Protector - SLGVS25US
2016-09-01
Dualex Plus Transducer Protector - SLGVS25PS
2016-09-01
Millex - FH - SLFH1000N
2016-09-01
Hydromillex - SLST025DM
2015-09-04
Dualex Ultra Transducer Protector - SLGVS25US
2015-09-04
Dualex Plus Transducer Protector - SLGVS25PS
2015-09-01
Millex - FH - SLFH1000N
2015-09-04
Dualex Transducer Protector - SLGVS25XS
2015-09-04
FOLLISTIM PEN STARTER KIT USA - 1022692
2019-11-14
FOLLISTIM PEN STARTER KIT SAM USA - 1746811
2019-10-28
FOLLISTIM AQ Cartridge 900IU - 1022679
2019-11-14
FOLLISTIM AQ Cartridge 600IU SAMPLE - 1746814
2019-10-28
FOLLISTIM AQ Cartridge 600IU - 1022678
2019-11-14
FOLLISTIM AQ Cartridge 300IU SAMPLE - 1746815
2019-10-28
FOLLISTIM AQ Cartridge 300IU - 1022677
2019-11-14
BCG Vaccine (Multiple Puncture Device) - 1039922
2023-04-10
Multiscreen-HV - MAHVN4550
2023-10-13
Multiscreen-HV - MAHVN4510
2023-10-13
Multiscreen-HTS HV - MSHVN4550
2023-10-13
Multiscreen-HTS HV - MSHVN4510
2023-10-13
Millex-VV - SLVVM33RS
2016-09-22
Millex-MP - SLMPL25SS
2016-09-22
Millex-MP - SLMP025SS
2016-09-22
Millex-HV - SLHVM33RS
2016-09-22
Vented Millex-GV - SLGVV255F
2016-09-22
Millex-HP - SLHPM33RS
2016-09-22
Millex-HA - SLHAM33SS
2016-09-22
Millex-GV - SLGVM33RS
2016-09-22
Cathivex-GV - SLGV0250S
2016-09-22
Millex-GS - SLGSM33SS
2016-09-22
Millex-GP - SLGPM33RS
2016-09-22
Millex-AA - SLAAM33SS
2016-09-22
BCG Vaccine (Multiple Puncture Device) - 1039922
2023-04-10
Minicon CS15 - 9051
2016-09-23
Amicon Ultra – 4 - UFC801096
2016-09-23
Amicon Ultra – 15 - UFC901008
2016-09-23
Amicon Ultra – 4 - UFC801024
2016-09-23
Amicon Ultra – 4 - UFC801008
2016-09-23