Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203510
Company: PARAGON BIOTECK
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
03/21/2013 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203510s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203510Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203510_phenylephrine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203510Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/08/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/21/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203510s000lbl.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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