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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203510
Company: PARAGON BIOTECK

Summary Review

Products on NDA 203510

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203510

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
12/08/2022	SUPPL-5		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203510s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203510Orig1s005ltr.pdf
04/17/2020	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203510s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203510Orig1s002ltr.pdf
10/08/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203510

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2022	SUPPL-5	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203510s005lbl.pdf
04/17/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203510s002lbl.pdf
04/17/2020	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203510s002lbl.pdf
03/21/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203510s000lbl.pdf

Therapeutic Equivalents for NDA 203510

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	ALCON
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	216859	MANKIND PHARMA
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	ALCON
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	216496	MANKIND PHARMA
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	203510	PARAGON BIOTECK

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