Calcitriol Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Rnabaxy Pharmaceuticals Inc. (2011-08-31)
Oldest Current Product
2003-07-18
License(s)
NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SOLUTION\CALCITRIOL
FDAOB
ORAL\SOLUTION\CALCITRIOL
SPL Active
ORAL\SOLUTION\CALCITRIOL
SPL Moiety
ORAL\SOLUTION\CALCITRIOL

product(s) by strength(s)

calcitriol 0.001 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543120ANDARoxane Laboratories, Inc2003-07-18CALCITRIOLORALSOLUTIONANDA0762423289b482-8733-484d-b1db-d7f4cdcd1ac2
2633040241NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2009-08-26CALCITRIOLORALSOLUTIONNDA02106866a69351-5b09-4368-a9fa-acf81b5ad882

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076242CALCITRIOLROXANE LABORATORIES INC2003-07-18ANDA076242_001
2NDA021068ROCALTROLVALIDUS PHARMACEUTICALS LLC1998-11-20NDA021068_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076242_001RXCALCITRIOL (1MCG/ML)ORALSOLUTIONFalseAA2003-07-18CALCITRIOL
2NDA021068_001RXCALCITRIOL (1MCG/ML)ORALSOLUTIONTrueAA1998-11-20ROCALTROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
13289b482-8733-484d-b1db-d7f4cdcd1ac2 (view SPL)CALCITRIOL Oral SolutionprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-01-268000543120
266a69351-5b09-4368-a9fa-acf81b5ad882 (view SPL)CALCITRIOL CAPSULES and ORAL SOLUTIONRx onlyprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.manufacture2011-08-312633040241, 633040239, 633040240Calcitriol Oral Capsule

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