Doxycycline Oral Suspension

Brand(s)
Vibramycin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-05-04)
Oldest Current Product
1967-12-06
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\DOXYCYCLINE
FDAOB
ORAL\FOR SUSPENSION\DOXYCYCLINE
ORAL\SUSPENSION\DOXYCYCLINE CALCIUM
SPL Active
ORAL\FOR SUSPENSION\DOXYCYCLINE
ORAL\POWDER, FOR SUSPENSION\DOXYCYCLINE
ORAL\SYRUP\DOXYCYCLINE CALCIUM
SPL Moiety
ORAL\FOR SUSPENSION\DOXYCYCLINE ANHYDROUS
ORAL\POWDER, FOR SUSPENSION\DOXYCYCLINE ANHYDROUS
ORAL\SYRUP\DOXYCYCLINE ANHYDROUS

product(s) by strength(s)

doxycycline calcium 10 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690971VibramycinNDAPfizer Labs1974-09-23DOXYCYCLINE CALCIUMORALSYRUPNDA050480d6f98d3c-5a20-4cbf-9a9c-abef10b9e465

doxycycline monohydrate 5 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690970VibramycinNDAPfizer Labs1967-12-06DOXYCYCLINEORALPOWDER, FOR SUSPENSIONNDA050006d6f98d3c-5a20-4cbf-9a9c-abef10b9e465

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674050475ANDAHarris Pharmaceutical, Inc.2008-07-16DOXYCYCLINEORALPOWDER, FOR SUSPENSIONANDA065454d6fe44ca-5e4d-4a5f-a7fd-e4c39866444a
2681800657ANDALupin Pharmaceuticals, Inc.2013-06-04DOXYCYCLINEORALFOR SUSPENSIONANDA201678e0e80435-1b6a-4361-8c8a-e432f8f23a1b
3690970228ANDACipla Usa Inc.2008-07-16DOXYCYCLINEORALPOWDER, FOR SUSPENSIONANDA0654549df39880-b2a7-483f-bbc3-c0be67492388

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA061720DOXYCHELTrueRACHELLE LABORATORIES INCANDA061720_001
2ANDA065454DOXYCYCLINECHARTWELL LIFE SCIENCE LLC2008-07-16ANDA065454_001
3ANDA201678DOXYCYCLINELUPIN LTD2013-03-18ANDA201678_001
4NDA050006VIBRAMYCINPFIZER LABORATORIES DIV PFIZER INCNDA050006_001
5NDA050480VIBRAMYCINPFIZER LABORATORIES DIV PFIZER INCNDA050480_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA061720_001discontinuedDOXYCYCLINE (EQ 25MG BASE/5ML)ORALFOR SUSPENSIONFalseDOXYCHEL
2ANDA065454_001RXDOXYCYCLINE (EQ 25MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2008-07-16DOXYCYCLINE
3ANDA201678_001RXDOXYCYCLINE (EQ 25MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2013-03-18DOXYCYCLINE
4NDA050006_001RXDOXYCYCLINE (EQ 25MG BASE/5ML)ORALFOR SUSPENSIONTrueABVIBRAMYCIN
5NDA050480_001RXDOXYCYCLINE CALCIUM (EQ 50MG BASE/5ML)ORALSUSPENSIONTrueVIBRAMYCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
19df39880-b2a7-483f-bbc3-c0be67492388 (view SPL)DOXYCYCLINE FOR ORAL SUSPENSION, USPprescriptionHuman PrescriptionCipla Usa Inc.2015-01-201690970228
2d6f98d3c-5a20-4cbf-9a9c-abef10b9e465 (view SPL)Vibramycin Calcium (doxycycline calcium oral suspension, USP) oral suspension SYRUP Vibramycin Hyclate (doxycycline hyclate capsules, USP) CAPSULES Vibramycin Monohydrate (doxycycline monohydrate) for ORAL SUSPENSION Vibra-Tabs (doxycycline hyclate tablets, USP) FILM COATED TABLETSprescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-05-0420000690970, 000690971, 000690950, 000690990Doxycycline Oral Capsule
3d6fe44ca-5e4d-4a5f-a7fd-e4c39866444a (view SPL)DOXYCYCLINE FOR ORAL SUSPENSION, USPprescriptionHuman PrescriptionHarris Pharmaceutical, Inc.2015-11-131674050475
4e0e80435-1b6a-4361-8c8a-e432f8f23a1b (view SPL)Doxycycline for Oral Suspension USPprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2015-10-078681800657

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