FDA.reportPublic FDA data

CATALENT

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18113961811396CATALENT PHARMA SOLUTIONS, LLC1N2026-01-012725 Scherer Drive North Saint Petersburg FL US 33716
14193771419377CATALENT PHARMA SOLUTIONS, LLC1N2020-04-252210 Lake Shore Dr Woodstock IL US 60098
30059499643005949964CATALENT INDIANA, LLC1N2020-04-251300 S Patterson Dr Bloomington IN US 47403
30076170943007617094CATALENT PHARMA SOLUTIONS, LLC1Y2020-04-2510381 Decatur Road Philadelphia PA US 19154

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
689511057294394K935540PARI-MASTER MODIFICATIONCAF1995-03-17
1229451707181745K170257Sydney IVF Culture OilMQL2017-02-24
1229452016359086K160814Sydney IVF Sperm Cryopreservation BufferMQL2016-04-22
1229451799321304K153478Sydney IVF Gamete BufferMQL2016-08-15
1229451773250970K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst MediumMQL2016-01-27
1229451055624160K152904SYDNEY IVF EMBRYO BIOPSY MEDIUMMQL2015-12-03
1229451681430997K152782SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENTMQL2015-12-21
1229451947288217K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitMQL2016-05-06
1229451223342305K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitMQL2016-05-05
1229451411804959K152440Sydney IVF PVPMQL2015-09-23
1229451044948546K151367Sydney IVF HyaluronidaseMQL2016-01-27
1229451900055301K143724COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming KitMQL2015-08-27
689511014245406K070498HYPER SALCAF2007-04-26
1685881641446688

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQL112017-02-24
CAF22007-04-26

Applications#