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Setid 4be7615b 70a5 4912 B4a5 09656cab2187 Applno 20837 Form Solution Inhalation Dosage Eq 0 042 Base - Drug Product Composition: Levalbuterol Hydrochloride

Levalbuterol Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 7 USDMF, 2 EU WC, 5 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

31 FDF Dossiers, 31 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

SOLUTION;INHALATION - EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Kirsch Pharma, 5 Actylis

EXCIPIENTS BY APPLICATIONS

5 Parenteral, 2 Controlled & Modified Release, 1 Thickeners and Stabilizers

DIGITAL CONTENT

7 News #PharmaBuzz

7 News #PharmaBuzz

GLOBAL SALES INFORMATION

11 US Medicaid Prescriptions, 5 Regulatory FDF Prices, 5 Annual Reports

MARKET PLACE

3 APIs

3 APIs

REF. STANDARDS & IMPURITIES

2 Others

2 Others

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USFDA APPLICATION NUMBER - 20837 / DOSAGE - SOLUTION;INHALATION - EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
levalbuterol hydrochloride(UNII: WDQ1526QJM) (LEVALBUTEROL - UNII:EDN2NBH5SS)	LEVALBUTEROL	1.25mg in 3

Inactive Ingredients

Ingredient Name	Cardinal Health	Sunovion Pharmaceuticals Inc.	Prasco Laboratories	REMEDYREPACK INC.	REMEDYREPACK INC.
hydrochloric acid(QTT17582CB)
NITROGEN(N762921K75)
sodium chloride(451W47IQ8X)
Sulfuric Acid(O40UQP6WCF)
water(059QF0KO0R)

Setid 4be7615b 70a5 4912 B4a5 09656cab2187 Applno 20837 Form Solution Inhalation Dosage Eq 0 042 Base - Drug Product Composition: Levalbuterol Hydrochloride

Levalbuterol Hydrochloride

Levalbuterol Hydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

21 API Suppliers

7 USDMF

2 EU WC

5 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

31 FDF Dossiers

31 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

SOLUTION;INHALATION - EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INHALATION - EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INHALATION - EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INHALATION - EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Kirsch Pharma

5 Actylis

EXCIPIENTS BY APPLICATIONS

5 Parenteral

2 Controlled & Modified Release

1 Thickeners and Stabilizers

DIGITAL CONTENT

7 News #PharmaBuzz

GLOBAL SALES INFORMATION

11 US Medicaid Prescriptions

5 Regulatory FDF Prices

5 Annual Reports

MARKET PLACE

3 APIs

REF. STANDARDS & IMPURITIES

2 Others

Filters

SOLUTION;INHALATION - EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INHALATION - EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INHALATION - EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INHALATION - EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons