FDA.reportPublic FDA data

Application 020439

Type
NDA
Sponsor
OAK PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETIMOLTIMOLOLSOLUTION/DROPS;OPHTHALMICEQ 0.25% BASEYesYes
002BETIMOLTIMOLOLSOLUTION/DROPS;OPHTHALMICEQ 0.5% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68669-522BetimoltimololVistakon Pharmaceuticals LLCNDACurrent
68669-525BetimoltimololVistakon Pharmaceuticals LLCNDACurrent
76478-001BetimolTimololAkornNDACurrent
76478-001BetimolTimololOak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)NDACurrent
76478-001BetimolTimololOak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719)NDACurrent
76478-002BetimolTimololAkornNDACurrent
76478-002BetimolTimololOak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)NDACurrent
76478-002BetimolTimololOak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719)NDACurrent
82584-001BETIMOLtimololThea Pharma Inc.NDACurrent
82584-002BETIMOLtimololThea Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12579SUPPL2004-11-01
24965SUPPL2004-10-29