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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207926
Company: ALCON

Products on NDA 207926

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	No
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207926

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

Labels for NDA 207926

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

Therapeutic Equivalents for NDA 207926

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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