Dimenhydrinate Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2011-08-23)
Oldest Current Product
2004-11-29
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\DIMENHYDRINATE
FDAOB
INJECTION\INJECTION\DIMENHYDRINATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\DIMENHYDRINATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\DIMENHYDRINATE

product(s) by strength(s)

dimenhydrinate 50 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230366ANDAApp Pharmaceuticals, Llc2004-11-29DIMENHYDRINATEINTRAMUSCULARINJECTION, SOLUTIONANDA040519bc71539e-1a33-4709-8a24-c2894e8dbc1c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040519DIMENHYDRINATEFRESENIUS KABI USA LLC2004-06-23ANDA040519_001
2ANDA080615DIMENHYDRINATETrueWATSON LABORATORIES INCANDA080615_001
3ANDA083531DIMENHYDRINATETrueWATSON LABORATORIES INCANDA083531_001
4ANDA084316DIMENHYDRINATETrueWYETH AYERST LABORATORIESANDA084316_001
5ANDA084767DIMENHYDRINATETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CAREANDA084767_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA040519_001RXDIMENHYDRINATE (50MG/ML)INJECTIONTrue2004-06-23DIMENHYDRINATE
2ANDA080615_001discontinuedDIMENHYDRINATE (50MG/ML)INJECTIONFalseDIMENHYDRINATE
3ANDA083531_001discontinuedDIMENHYDRINATE (50MG/ML)INJECTIONFalseDIMENHYDRINATE
4ANDA084316_001discontinuedDIMENHYDRINATE (50MG/ML)INJECTIONFalseDIMENHYDRINATE
5ANDA084767_001discontinuedDIMENHYDRINATE (50MG/ML)INJECTIONFalseDIMENHYDRINATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1bc71539e-1a33-4709-8a24-c2894e8dbc1c (view SPL)Dimenhydrinate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-08-231633230366

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