Cyclopentolate / Phenylephrine Ophthalmic Solution

Brand(s)
Cyclomydril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-08-03)
Oldest Current Product
1958-06-30
License(s)
ANDA
RxNORM
OPHTHALMIC SOLUTION\CYCLOPENTOLATE:PHENYLEPHRINE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\CYCLOPENTOLATE HYDROCHLORIDE: PHENYLEPHRINE HYDROCHLORIDE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\CYCLOPENTOLATE HYDROCHLORIDE: PHENYLEPHRINE HYDROCHLORIDE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\CYCLOPENTOLATE: PHENYLEPHRINE

product(s) by strength(s)

cyclopentolate hydrochloride 2 mg/ml / phenylephrine hydrochloride 10 mg/ml ophthalmic solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000650359CyclomydrilANDAAlcon Laboratories, Inc.1958-06-30CYCLOPENTOLATE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSANDA0843008268b70f-3f10-48dd-bb24-baaeb27a1325

application(s)

#idtitleapplicantapproved drug
1ANDA084300CYCLOMYDRILALCON LABORATORIES INCANDA084300_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1ANDA084300_001RXPHENYLEPHRINE HYDROCHLORIDE (1%), CYCLOPENTOLATE HYDROCHLORIDE (0.2%)OPHTHALMICSOLUTION/DROPSTrueCYCLOMYDRIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18268b70f-3f10-48dd-bb24-baaeb27a1325 (view SPL)Cyclomydril (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) SterileprescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-08-035000650359

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