Dicyclomine Injectable Solution

Brand(s)
Bentyl
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aptalis Pharma Inc. (2013-06-18)
Oldest Current Product
1952-08-13
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\DICYCLOMINE
FDAOB
INJECTION\INJECTION\DICYCLOMINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\DICYCLOMINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\DICYCLOMINE

product(s) by strength(s)

dicyclomine hydrochloride 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1589140080BentylNDAAptalis Pharma Inc.1952-08-13DICYCLOMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA008370c56598d5-9cd1-4cce-b172-ac338775aec7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040465DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE)EUROHEALTH INTERNATIONAL SARL2003-06-30ANDA040465_001
2ANDA080614DICYCLOMINE HYDROCHLORIDETrueWATSON LABORATORIES INC1986-02-11ANDA080614_001
3NDA008370BENTYLFOREST LABORATORIES INC1984-10-15NDA008370_001, NDA008370_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040465_001RXDICYCLOMINE HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2003-06-30DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE)
2ANDA080614_001discontinuedDICYCLOMINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1986-02-11DICYCLOMINE HYDROCHLORIDE
3NDA008370_001RXDICYCLOMINE HYDROCHLORIDE (10MG/ML)INJECTIONTrueAP1984-10-15BENTYL
4NDA008370_002RXDICYCLOMINE HYDROCHLORIDE (10MG/ML)INJECTIONTrueAP1984-10-15BENTYL

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
1c56598d5-9cd1-4cce-b172-ac338775aec7 (view SPL)These highlights do not include all the information needed to use BENTYL safely and effectively. See full prescribing information for BENTYL. Initial U.S. Approval: 1950 BENTYL (Dicyclomine hydrochloride USP)prescriptionHuman PrescriptionAptalis Pharma Inc.2013-06-1811589140080, 589140012, 589140013Dicyclomine Oral Tablet
Dicyclomine Oral Capsule

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