Application 212520

Type
NDA
Sponsor
RVL PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UPNEEQOXYMETAZOLINE HYDROCHLORIDESOLUTION;OPHTHALMIC0.1%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73687-062UPNEEQOxymetazoline hydrochloride ophthalmicRVL Pharmaceuticals, Inc.NDACurrent
73687-062UPNEEQOxymetazoline hydrochloride ophthalmicRVL Pharmaceuticals, Inc.NDACurrent
73687-062UPNEEQOxymetazoline hydrochloride ophthalmicRVL Pharmaceuticals, Inc.NDACurrent
73687-062UPNEEQOxymetazoline hydrochloride ophthalmicRVL Pharmaceuticals, Inc.NDACurrent
73687-062UPNEEQOxymetazoline hydrochloride ophthalmicRVL Pharmaceuticals, Inc.NDACurrent
73687-062UPNEEQOxymetazoline hydrochloride ophthalmicRVL Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67432SUPPL2021-05-07
67418SUPPL2021-05-05
66999ORIG2021-04-07
64290SUPPL2020-08-17
64287SUPPL2020-08-17
63835ORIG2020-07-09
63829ORIG2020-07-09