FDA.reportPublic FDA data

Application 206306

Type
ANDA
Sponsor
SOMERSET THERAPS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.1% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3566OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3566OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3566OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
53002-0510OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
68071-5085OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-5085OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
70069-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESomerset Therapeutics, LLCANDACurrent
70069-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESomerset Therapeutics, LLCANDACurrent
70069-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESomerset Therapeutics, LLCANDACurrent
70069-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESomerset Therapeutics, LLCANDACurrent
71205-345OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEProficient Rx LPANDACurrent
71205-345OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEProficient Rx LPANDACurrent
71205-345OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEProficient Rx LPANDACurrent
76420-089OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAsclemed USA, Inc.ANDACurrent
76519-1161OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEH.J. Harkins Company, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32794ORIG2015-12-09