Pilocarpine Ophthalmic Solution

Brand(s)
Isoptocarpine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-06-21)
Oldest Current Product
1974-01-01
License(s)
NDA
RxNORM
OPHTHALMIC SOLUTION\PILOCARPINE
FDAOB
OPHTHALMIC\SOLUTION\PILOCARPINE HYDROCHLORIDE
SPL Active
CONJUNCTIVAL\SOLUTION/DROPS\PILOCARPINE HYDROCHLORIDE
OPHTHALMIC\SOLUTION\PILOCARPINE HYDROCHLORIDE
SPL Moiety
CONJUNCTIVAL\SOLUTION/DROPS\PILOCARPINE
OPHTHALMIC\SOLUTION\PILOCARPINE

product(s) by strength(s)

pilocarpine hydrochloride 10 mg/ml ophthalmic solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1613140203NDASandoz Inc1996-02-21PILOCARPINE HYDROCHLORIDEOPHTHALMICSOLUTIONNDA20089053fa0b7a-f982-48a7-92c4-6f098683c1ed

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950368NDARebel Distributors Corp2010-06-22PILOCARPINE HYDROCHLORIDECONJUNCTIVALSOLUTION/DROPS613140203NDA200890d2ded29a-448d-4c4a-9307-403836a67da4

pilocarpine hydrochloride 20 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009980204IsoptocarpineNDAAlcon Laboratories, Inc.1974-01-01PILOCARPINE HYDROCHLORIDEOPHTHALMICSOLUTIONNDA20089022e4c7f4-bbd0-4e74-85da-bb56fc377568

pilocarpine hydrochloride 40 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009980206IsoptocarpineNDAAlcon Laboratories, Inc.1974-01-01PILOCARPINE HYDROCHLORIDEOPHTHALMICSOLUTIONNDA20089022e4c7f4-bbd0-4e74-85da-bb56fc377568

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250502NDARemedyrepack Inc.2013-04-15PILOCARPINE HYDROCHLORIDEOPHTHALMICSOLUTION613140206NDA200890d87192c5-c6b4-4d56-95b1-bb242afed3c1

application(s)

#idtitleapplicantapprovedapproved drug
1NDA200890ISOPTO CARPINEALCON RESEARCH LTD2010-06-22NDA200890_001, NDA200890_002, NDA200890_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200890_001RXPILOCARPINE HYDROCHLORIDE (1%)OPHTHALMICSOLUTIONFalse2010-06-22ISOPTO CARPINE
2NDA200890_002RXPILOCARPINE HYDROCHLORIDE (2%)OPHTHALMICSOLUTIONFalse2010-06-22ISOPTO CARPINE
3NDA200890_003RXPILOCARPINE HYDROCHLORIDE (4%)OPHTHALMICSOLUTIONTrue2010-06-22ISOPTO CARPINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
122e4c7f4-bbd0-4e74-85da-bb56fc377568 (view SPL)These highlights do not include all the information needed to use Isopto Carpine safely and effectively. See full prescribing information for Isopto Carpine. Isopto Carpine (pilocarpine hydrochloride ophthalmic solution) 1%, 2% and 4% Initial U.S. Approval: 1974prescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-06-217009980204, 009980206, 009980203
253fa0b7a-f982-48a7-92c4-6f098683c1ed (view SPL)These highlights do not include all the information needed to use Pilocarpine Hydrochloride Ophthalmic Solution safely and effectively. See full prescribing information for Pilocarpine Hydrochloride Ophthalmic Solution. Pilocarpine Hydrochloride Ophthalmic Solution 1%, 2% and 4% Initial U.S. Approval: 1974prescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-06-211613140203
3d2ded29a-448d-4c4a-9307-403836a67da4 (view SPL)Pilocarpine Hydrochloride Ophthalmic Solution USP (Sterile)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-03-151216950368
4d87192c5-c6b4-4d56-95b1-bb242afed3c1 (view SPL)These highlights do not include all the information needed to use Pilocarpine Hydrochloride Ophthalmic Solution safely and effectively. See full prescribing information for Pilocarpine Hydrochloride Ophthalmic Solution.Pilocarpine Hydrochloride Ophthalmic Solution 1%, 2% and 4%Initial U.S. Approval: 1974prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-151521250502

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