Citalopram Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Silarx Pharmaceuticals, Inc (2014-06-27)
Oldest Current Product
2004-05-25
License(s)
ANDA
RxNORM
ORAL SOLUTION\CITALOPRAM
FDAOB
ORAL\SOLUTION\CITALOPRAM HYDROBROMIDE
SPL Active
ORAL\SOLUTION\CITALOPRAM HYDROBROMIDE
SPL Moiety
ORAL\SOLUTION\CITALOPRAM

product(s) by strength(s)

citalopram 2 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1548380540ANDASilarx Pharmaceuticals, Inc2006-06-14CITALOPRAM HYDROBROMIDEORALSOLUTIONANDA077629a6ad0d10-3d6b-454c-a5a1-d95079befc48
2572370148ANDACitron Pharma Llc2006-08-28CITALOPRAM HYDROBROMIDEORALSOLUTIONANDA0778129ae8fc56-d297-4514-869f-0b7e31ad65dd
3658620074ANDAAurobindo Pharma Limited2006-08-28CITALOPRAM HYDROBROMIDEORALSOLUTIONANDA077812e7a2cbdd-1bdb-4e59-a3dd-298a189753ae

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540062ANDARoxane Laboratories, Inc2004-05-25CITALOPRAM HYDROBROMIDEORALSOLUTIONANDA00000029408d84-7b00-4cee-969c-8095f8083ff5

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077043CITALOPRAM HYDROBROMIDEROXANE LABORATORIES INC2004-12-13ANDA077043_001
2ANDA077601CITALOPRAM HYDROBROMIDETrueAPOTEX INC2005-11-15ANDA077601_001
3ANDA077629CITALOPRAM HYDROBROMIDESILARX PHARMACEUTICALS INC2006-06-15ANDA077629_001
4ANDA077812CITALOPRAM HYDROBROMIDEAUROBINDO PHARMA LTD INC2006-08-28ANDA077812_001
5NDA021046CELEXATrueFOREST LABORATORIES INC1999-12-22NDA021046_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077043_001RXCITALOPRAM HYDROBROMIDE (EQ 10MG BASE/5ML)ORALSOLUTIONTrueAA2004-12-13CITALOPRAM HYDROBROMIDE
2ANDA077601_001discontinuedCITALOPRAM HYDROBROMIDE (EQ 10MG BASE/5ML)ORALSOLUTIONFalse2005-11-15CITALOPRAM HYDROBROMIDE
3ANDA077629_001RXCITALOPRAM HYDROBROMIDE (EQ 10MG BASE/5ML)ORALSOLUTIONFalseAA2006-06-15CITALOPRAM HYDROBROMIDE
4ANDA077812_001RXCITALOPRAM HYDROBROMIDE (EQ 10MG BASE/5ML)ORALSOLUTIONFalseAA2006-08-28CITALOPRAM HYDROBROMIDE
5NDA021046_001discontinuedCITALOPRAM HYDROBROMIDE (EQ 10MG BASE/5ML)ORALSOLUTIONFalse1999-12-22CELEXA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
129408d84-7b00-4cee-969c-8095f8083ff5 (view SPL)CITALOPRAM Oral Solution USP, 10 mg/5 mLprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-05-0911000540062
29ae8fc56-d297-4514-869f-0b7e31ad65dd (view SPL)Citalopram Oral Solution, USPRx onlyprescriptionHuman PrescriptionCitron Pharma Llc2015-09-141572370148
3a6ad0d10-3d6b-454c-a5a1-d95079befc48 (view SPL)Citalopram Oral Solution, USPprescriptionHuman PrescriptionSilarx Pharmaceuticals, Inc2014-06-2720548380540
4e7a2cbdd-1bdb-4e59-a3dd-298a189753ae (view SPL)Citalopram Oral Solution, USPRx OnlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-05-2310658620074

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII