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FDA Approval

ProAir RespiClick

CompanyRPK Pharmaceuticals, Inc. (DUNS: 147096275)

Effective Date

June 7, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Salbutamol(90 ug in 1 1)

Manufacturing Establishments (1)

RPK Pharmaceuticals, Inc.

Labeler

RPK Pharmaceuticals, Inc.

DUNS Number

147096275

Products (1)

ProAir RespiClick

NDC Product Code

53002-1750

Application Number

NDA205636

Marketing Category

NDA (C73594)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

September 27, 2022

Ingredients

SalbutamolActive

Code: 021SEF3731Class: ACTIMQuantity: 90 ug in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

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