Dexamethasone Oral Solution

Brand(s)
Baycadron
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2015-02-27)
Oldest Current Product
1976-09-21
License(s)
ANDA
RxNORM
ORAL SOLUTION\DEXAMETHASONE
FDAOB
ORAL\CONCENTRATE\DEXAMETHASONE
ORAL\ELIXIR\DEXAMETHASONE
ORAL\SOLUTION\DEXAMETHASONE
SPL Active
ORAL\ELIXIR\DEXAMETHASONE
ORAL\SOLUTION, CONCENTRATE\DEXAMETHASONE
ORAL\SOLUTION\DEXAMETHASONE
SPL Moiety
ORAL\ELIXIR\DEXAMETHASONE
ORAL\SOLUTION, CONCENTRATE\DEXAMETHASONE
ORAL\SOLUTION\DEXAMETHASONE

product(s) by strength(s)

dexamethasone 0.1 mg/ml oral solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543177ANDARoxane Laboratories, Inc2007-11-01DEXAMETHASONEORALSOLUTIONANDA088248b15200fb-1826-472b-a907-e677a272513b
2006031147ANDAQualitest Pharmaceuticals2011-05-11DEXAMETHASONEORALELIXIRANDA091188ce01733f-33b7-483e-9bc4-cf43937e6998
3548790003ANDASti Pharma1976-09-21DEXAMETHASONEORALELIXIRANDA084754320747b3-5cf1-4e0c-b670-c6a9e72a8845
4604320466ANDAMorton Grove Pharmaceuticals, Inc.1983-07-27DEXAMETHASONEORALELIXIRANDA088254c6eb10d2-2251-482b-8a57-fea31c05bc7e
5646790810BaycadronANDAWockhardt Usa Llc.1983-07-27DEXAMETHASONEORALELIXIRANDA088254e59d3b87-af2e-4262-b89d-e95aa79f11b7
6649800509ANDARising Pharmaceuticals, Inc.2011-08-01DEXAMETHASONEORALELIXIRANDA0908917cf5c17c-a80b-4547-83b2-0d53e2b933f7
7688500001ANDASti Pharma Llc1976-09-21DEXAMETHASONEORALELIXIRANDA08475420d1ffa7-0a0a-4a16-a2ec-347c21693e80

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551543275ANDACardinal Health1983-07-27DEXAMETHASONEORALELIXIR604320466ANDA088254dfb8cd15-e468-4082-8e68-4f1d4ad7f283

dexamethasone 1 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543176ANDARoxane Laboratories, Inc1983-09-01DEXAMETHASONEORALSOLUTION, CONCENTRATEANDA088252b15200fb-1826-472b-a907-e677a272513b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681515026ANDACarilion Materials Management1983-09-01DEXAMETHASONEORALSOLUTION, CONCENTRATE000543176ANDA088252a817ab46-54ec-4e3f-886b-04ce6ac1caf9

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA084754DEXAMETHASONESTI PHARMA LLCANDA084754_001
2ANDA088248DEXAMETHASONEROXANE LABORATORIES INC1983-09-01ANDA088248_001
3ANDA088252DEXAMETHASONE INTENSOLROXANE LABORATORIES INC1983-09-01ANDA088252_001
4ANDA088254DEXAMETHASONEWOCKHARDT EU OPERATIONS SWISS AG1983-07-27ANDA088254_001
5ANDA088997DEXAMETHASONETrueALPHARMA US PHARMACEUTICALS DIVISION1986-10-10ANDA088997_001
6ANDA090891DEXAMETHASONELYNE LABORATORIES INC2011-07-12ANDA090891_001
7ANDA091188DEXAMETHASONEVINTAGE PHARMACEUTICALS INC2011-05-11ANDA091188_001
8NDA012376DECADRONTrueMERCK AND CO INCNDA012376_002
9NDA012674HEXADROLTrueORGANON USA INCNDA012674_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA084754_001RXDEXAMETHASONE (0.5MG/5ML)ORALELIXIRTrueAADEXAMETHASONE
2ANDA088248_001RXDEXAMETHASONE (0.5MG/5ML)ORALSOLUTIONTrue1983-09-01DEXAMETHASONE
3ANDA088252_001RXDEXAMETHASONE (1MG/ML)ORALCONCENTRATETrue1983-09-01DEXAMETHASONE INTENSOL
4ANDA088254_001RXDEXAMETHASONE (0.5MG/5ML)ORALELIXIRFalseAA1983-07-27DEXAMETHASONE
5ANDA088997_001discontinuedDEXAMETHASONE (0.5MG/5ML)ORALELIXIRFalse1986-10-10DEXAMETHASONE
6ANDA090891_001RXDEXAMETHASONE (0.5MG/5ML)ORALELIXIRFalseAA2011-07-12DEXAMETHASONE
7ANDA091188_001RXDEXAMETHASONE (0.5MG/5ML)ORALELIXIRFalseAA2011-05-11DEXAMETHASONE
8NDA012376_002discontinuedDEXAMETHASONE (0.5MG/5ML)ORALELIXIRFalseDECADRON
9NDA012674_001discontinuedDEXAMETHASONE (0.5MG/5ML)ORALELIXIRFalseHEXADROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
120d1ffa7-0a0a-4a16-a2ec-347c21693e80 (view SPL)DEXAMETHASONE ELIXIR, USP0.5 mg / 5 mLprescriptionHuman PrescriptionSti Pharma Llc2012-08-142688500001
2320747b3-5cf1-4e0c-b670-c6a9e72a8845 (view SPL)DEXAMETHASONE ELIXIR, USP0.5 mg / 5 mLprescriptionHuman PrescriptionSti Pharma2011-12-013548790003
37cf5c17c-a80b-4547-83b2-0d53e2b933f7 (view SPL)prescriptionHuman PrescriptionRising Pharmaceuticals, Inc.manufacture2011-08-195649800509
4a817ab46-54ec-4e3f-886b-04ce6ac1caf9 (view SPL)DEXAMETHASONE Tablets USP, DEXAMETHASONE Oral Solution, and DEXAMETHASONE Intensol Oral Solution (Concentrate)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2009-08-312681515026
5b15200fb-1826-472b-a907-e677a272513b (view SPL)prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-02-272000543176, 000543177, 000544179, 000544180, 000544181, 000544182, 000544183, 000544184, 000544186, 000548174, 000548175, 000548176, 000548179, 000548180, 000548181, 000548183Dexamethasone Oral Tablet
6c6eb10d2-2251-482b-8a57-fea31c05bc7e (view SPL)DEXAMETHASONE ELIXIR, USP (0.5 mg/5 mL)prescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.API MANUFACTURE2012-01-302604320466
7ce01733f-33b7-483e-9bc4-cf43937e6998 (view SPL)DEXAMETHASONE ELIXIR, USP 0.5 mg/5 mLprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-04-073006031147
8dfb8cd15-e468-4082-8e68-4f1d4ad7f283 (view SPL)DEXAMETHASONE ELIXIR, USP (0.5 mg/5 mL)prescriptionHuman PrescriptionCardinal HealthREPACK2013-03-191551543275
9e59d3b87-af2e-4262-b89d-e95aa79f11b7 (view SPL)BAYCADRON ELIXIR (Dexamethasone Elixir, USP 0.5 mg/5 mL)prescriptionHuman PrescriptionWockhardt Usa Llc.2009-07-154646790810

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