Paromomycin Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Caraco Pharmaceutical Laboratories, Ltd.
Oldest Current Product
1997-10-01
License(s)
ANDA
RxNORM
ORAL CAPSULE\PAROMOMYCIN
FDAOB
ORAL\CAPSULE\PAROMOMYCIN SULFATE
SPL Active
ORAL\CAPSULE\PAROMOMYCIN SULFATE
SPL Moiety
ORAL\CAPSULE\PAROMOMYCIN

product(s) by strength(s)

paromomycin 250 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550038ANDAHeritage Pharmaceuticals Inc.2009-10-22PAROMOMYCIN SULFATEORALCAPSULEANDA065173cc0f4113-e627-4caf-b2d4-95b4106e57f5
2576640175ANDACaraco Pharmaceutical Laboratories, Ltd.1997-10-01PAROMOMYCIN SULFATEORALCAPSULEANDA06417122494bde-a53e-4b3c-a89b-0ccda341f28f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060521HUMATINTruePARKEDALE PHARMACEUTICALS INCANDA060521_001
2ANDA062310HUMATINTrueKING PHARMACEUTICALS INC SUB PFIZER INCANDA062310_001
3ANDA064171PAROMOMYCIN SULFATESUN PHARMACEUTICAL INDUSTRIES INC1997-06-30ANDA064171_001
4ANDA065173PAROMOMYCIN SULFATEHERITAGE PHARMACEUTICALS INC2007-12-14ANDA065173_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060521_001discontinuedPAROMOMYCIN SULFATE (EQ 250MG BASE)ORALCAPSULEFalseHUMATIN
2ANDA062310_001discontinuedPAROMOMYCIN SULFATE (EQ 250MG BASE)ORALCAPSULEFalseHUMATIN
3ANDA064171_001RXPAROMOMYCIN SULFATE (EQ 250MG BASE)ORALCAPSULETrueAA1997-06-30PAROMOMYCIN SULFATE
4ANDA065173_001RXPAROMOMYCIN SULFATE (EQ 250MG BASE)ORALCAPSULEFalseAA2007-12-14PAROMOMYCIN SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
122494bde-a53e-4b3c-a89b-0ccda341f28f (view SPL)Paromomycin Sulfate Capsules, USPprescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE2576640175
2cc0f4113-e627-4caf-b2d4-95b4106e57f5 (view SPL)Paromomycin Sulfate Capsules, USP Rx OnlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2014-01-086231550038

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