FDA.reportPublic FDA data

Application 021516

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISTALOLTIMOLOL MALEATESOLUTION/DROPS;OPHTHALMICEQ 0.5% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-004IstalolTimolol MaleateBausch & Lomb IncorporatedNDACurrent
24208-004IstalolTimolol MaleateBausch & Lomb IncorporatedNDACurrent
24208-004IstalolTimolol MaleateBausch & Lomb IncorporatedNDACurrent
24208-004IstalolTimolol MaleateBausch & Lomb IncorporatedNDACurrent
24208-004IstalolTimolol MaleateBausch & Lomb IncorporatedNDACurrent
24208-004IstalolTimolol MaleateBausch & Lomb IncorporatedNDACurrent
68682-045Timolol MaleateTimolol MaleateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-045Timolol MaleateTimolol MaleateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
82260-045Timolol MaleateTimolol MaleateBausch & Lomb Americas Inc.NDA AUTHORIZED GENERICCurrent
82260-045Timolol MaleateTimolol MaleateBausch & Lomb Americas Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
28005SUPPL2013-06-19
15659SUPPL2013-06-17
21710ORIG2006-01-31
15658ORIG2004-06-10
5601ORIG2004-06-10