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FDA Approval

UPNEEQ

CompanyRVL Pharmaceuticals, Inc. (DUNS: 081365086)

Effective Date

May 9, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oxymetazoline(1 mg in 1 mL)

Products (1)

UPNEEQ

NDC Product Code

73687-062

Application Number

NDA212520

Marketing Category

NDA (C73594)

Route of Administration

OPHTHALMIC

Effective Date

May 9, 2023

Ingredients

OxymetazolineActive

Code: K89MJ0S5VYClass: ACTIBQuantity: 1 mg in 1 mL

CALCIUM CHLORIDEInactive

Code: M4I0D6VV5MClass: IACT

MAGNESIUM CHLORIDEInactive

Code: 02F3473H9OClass: IACT

POTASSIUM CHLORIDEInactive

Code: 660YQ98I10Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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