Etidronate Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-04-16)
Oldest Current Product
2008-01-02
License(s)
ANDA
RxNORM
ORAL TABLET\ETIDRONATE
FDAOB
ORAL\TABLET\ETIDRONATE DISODIUM
SPL Active
ORAL\TABLET\ETIDRONATE DISODIUM
SPL Moiety
ORAL\TABLET\ETIDRONIC ACID

product(s) by strength(s)

etidronate disodium 200 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783286ANDAMylan Pharmaceuticals Inc.2008-01-02ETIDRONATE DISODIUMORALTABLETANDA075800fa07734d-b381-4f33-a555-53b6614f4b08

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681511521ANDACarilion Materials Management2008-01-02ETIDRONATE DISODIUMORALTABLET003783286ANDA075800dcbd076e-3989-4cae-9466-54a0e9118128

etidronate disodium 400 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783288ANDAMylan Pharmaceuticals Inc.2008-01-02ETIDRONATE DISODIUMORALTABLETANDA075800fa07734d-b381-4f33-a555-53b6614f4b08

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA075800ETIDRONATE DISODIUMMYLAN PHARMACEUTICALS INC2003-01-24ANDA075800_001, ANDA075800_002
2NDA017831DIDRONELPROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CONDA017831_001, NDA017831_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075800_001RXETIDRONATE DISODIUM (200MG)ORALTABLETFalseAB2003-01-24ETIDRONATE DISODIUM
2ANDA075800_002RXETIDRONATE DISODIUM (400MG)ORALTABLETFalseAB2003-01-24ETIDRONATE DISODIUM
3NDA017831_001RXETIDRONATE DISODIUM (200MG)ORALTABLETFalseABDIDRONEL
4NDA017831_002RXETIDRONATE DISODIUM (400MG)ORALTABLETTrueABDIDRONEL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1dcbd076e-3989-4cae-9466-54a0e9118128 (view SPL)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-01-202681511521
2fa07734d-b381-4f33-a555-53b6614f4b08 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-04-167003783286, 003783288

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