Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207926
Company: AKORN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/15/2015 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207926s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207926Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207926Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/01/2019 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207926s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207926Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/01/2019 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207926s002lbl.pdf
01/15/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207926s000lbl.pdf

PHENYLEPHRINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; 2.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 207926 AKORN INC
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 2.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 203510 PARAGON BIOTECK

SOLUTION/DROPS;OPHTHALMIC; 10%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 207926 AKORN INC
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 203510 PARAGON BIOTECK

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