FDA.reportPublic FDA data

Application 200890

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOPTO CARPINEPILOCARPINE HYDROCHLORIDESOLUTION;OPHTHALMIC1%YesNo
002ISOPTO CARPINEPILOCARPINE HYDROCHLORIDESOLUTION;OPHTHALMIC2%YesNo
003ISOPTO CARPINEPILOCARPINE HYDROCHLORIDESOLUTION;OPHTHALMIC4%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0998-0203ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0203ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0203ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0203ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0204ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0204ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0204ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0204ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0206ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0206ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0206ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0998-0206ISOPTO CARPINEpilocarpine hydrochlorideAlcon Laboratories, Inc.NDACurrent
21695-368PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDERebel Distributors CorpNDACurrent
61314-203Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-203Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz Inc.NDA AUTHORIZED GENERICCurrent
61314-203Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-203Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-204Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-204Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz Inc.NDA AUTHORIZED GENERICCurrent
61314-204Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-204Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-206Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-206Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz Inc.NDA AUTHORIZED GENERICCurrent
61314-206Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-206Pilocarpine Hydrochloridepilocarpine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44828ORIG2010-09-14
43358ORIG2010-09-14
32070SUPPL2010-07-12
18985SUPPL2010-07-12
9852ORIG2010-06-29
40048ORIG2010-06-24
54125ORIG1900-01-01
54124ORIG1900-01-01
54123ORIG1900-01-01