Hydrocortisone Enema

Brand(s)
Colocort, Cortenema
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Anip Acquisition Company (2015-05-22)
Oldest Current Product
1999-12-31
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ENEMA\HYDROCORTISONE
FDAOB
RECTAL\ENEMA\HYDROCORTISONE
SPL Active
RECTAL\ENEMA\HYDROCORTISONE
RECTAL\SUSPENSION\HYDROCORTISONE
SPL Moiety
RECTAL\ENEMA\HYDROCORTISONE
RECTAL\SUSPENSION\HYDROCORTISONE

product(s) by strength(s)

hydrocortisone 1.67 mg/ml enema

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1519910728NDABreckenridge Pharmaceutical, Inc.2010-10-15HYDROCORTISONERECTALSUSPENSIONNDA0161995f8b9adc-6e3a-4fec-9127-f58f74406ce6

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005742020ColocortANDAPaddock Laboratories, Llc1999-12-31HYDROCORTISONERECTALSUSPENSIONANDA075172a5b47406-b933-4f6b-96dc-db837bcccf77
2625590138NDA AUTHORIZED GENERICAnip Acquisition Company2012-08-16HYDROCORTISONERECTALENEMANDA01619940654d12-56e4-4489-be49-19c60ad918ad

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074171HYDROCORTISONETEVA PHARMACEUTICALS USA1994-05-27ANDA074171_001
2ANDA075172COLOCORTPADDOCK LABORATORIES LLC1999-12-03ANDA075172_001
3NDA016199CORTENEMAANI PHARMACEUTICALS INCNDA016199_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074171_001RXHYDROCORTISONE (100MG/60ML)RECTALENEMAFalseAB1994-05-27HYDROCORTISONE
2ANDA075172_001RXHYDROCORTISONE (100MG/60ML)RECTALENEMAFalseAB1999-12-03COLOCORT
3NDA016199_001RXHYDROCORTISONE (100MG/60ML)RECTALENEMATrueABCORTENEMA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
140654d12-56e4-4489-be49-19c60ad918ad (view SPL)Hydrocortisone Rectal Suspension, USP (Retention) 100 mg / 60 mL DISPOSABLE UNIT FOR RECTAL USE ONLYprescriptionHuman PrescriptionAnip Acquisition Company2015-05-222625590138
25f8b9adc-6e3a-4fec-9127-f58f74406ce6 (view SPL)Hydrocortisone Rectal Suspension, USP (Retention) 100 mg/60 mLprescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2012-03-142519910728
3a307448a-ccc4-41a8-977a-11f28f0bded9 (view SPL)CORTENEMAhydrocortisone retention enema100 mg / 60 mLDISPOSABLE UNIT FOR RECTAL USE ONLYprescriptionHuman PrescriptionAnip Acquisition Company2012-08-131625590111
4a5b47406-b933-4f6b-96dc-db837bcccf77 (view SPL)COLOCORT Hydrocortisone Rectal Suspension, USP (Retention) 100 mg/60 mLprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-10-016005742020

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