FDA.reportPublic FDA data

Application 020597

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XALATANLATANOPROSTSOLUTION/DROPS;OPHTHALMIC0.005%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0013-8303XalatanlatanoprostPfizer Laboratories Div Pfizer IncNDACurrent
0013-8303XalatanlatanoprostPharmacia and Upjohn Company LLCNDACurrent
0013-8303XalatanlatanoprostPharmacia and Upjohn Company LLCNDACurrent
0013-8303XalatanlatanoprostPFIZER LABORATORIES DIV PFIZER INCNDACurrent
0013-8303XalatanlatanoprostPharmacia and Upjohn Company LLCNDACurrent
0013-8303XalatanlatanoprostPharmacia and Upjohn Company LLCNDACurrent
0013-8303XalatanlatanoprostPfizer Laboratories Div Pfizer IncNDACurrent
0013-8303XalatanlatanoprostPharmacia and Upjohn CompNDACurrent
59762-0333LatanoprostLatanoprostGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0333LatanoprostLatanoprostGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0333LatanoprostLatanoprostGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0333LatanoprostLatanoprostGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0333LatanoprostLatanoprostGreenstone LLCNDA AUTHORIZED GENERICCurrent
68258-8976XalatanlatanoprostDispensing Solutions, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72966SUPPL2022-12-21
64506SUPPL2020-09-04
64476SUPPL2020-09-02
57805ORIG2019-02-15
48025SUPPL2017-04-14
48008SUPPL2017-04-13
34935SUPPL2014-12-03
12817SUPPL2014-12-03
2837SUPPL2014-11-28
2836SUPPL2014-11-28
12818SUPPL2013-03-15
34934SUPPL2012-03-16
25288SUPPL2012-03-15
41464SUPPL2012-01-27
41463SUPPL2012-01-27
20754SUPPL2012-01-27
20753SUPPL2012-01-27
34933SUPPL2010-09-07
12816SUPPL2010-09-07
2835SUPPL2010-09-07
2834SUPPL2010-09-07
2833SUPPL2003-07-28
2832SUPPL2003-07-28
12814SUPPL2003-04-28
12813SUPPL2003-04-28
25286SUPPL2003-04-04
12812SUPPL2003-04-04
25287SUPPL2002-08-26
12815SUPPL2002-08-26