FDA.reportPublic FDA data

Application 203510

Type
NDA
Sponsor
PARAGON BIOTECK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC2.5%YesYes
002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC10%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42702-102Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-102Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-102Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-102Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-102Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-102Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-103Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-103Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-103Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-103Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-103Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent
42702-103Phenylephrine Hydrochloridephenylephrine hydrochlorideParagon BioTeck, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72851SUPPL2022-12-09
72838SUPPL2022-12-09
62670SUPPL2020-04-24
62597SUPPL2020-04-20
24437ORIG2013-09-20
22925ORIG2013-09-20
19479ORIG2013-03-26
32435ORIG2013-03-22
64047ORIG1900-01-01
51566ORIG1900-01-01
51565ORIG1900-01-01
51564ORIG1900-01-01