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Levalbuterol
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Levalbuterol

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ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 7 USDMF, 2 EU WC, 5 NDC API, 14 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SOLUTION;INHALATION - EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

5 Actylis

5 Actylis

EXCIPIENTS BY APPLICATIONS

3 Parenteral, 2 Controlled & Modified Release

DIGITAL CONTENT

7 News #PharmaBuzz

7 News #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

3 APIs

3 APIs

REF. STANDARDS & IMPURITIES

4 USP, 10 Others

$ Xls download

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Aspen API	Netherlands	FINE CHEMICALS CORP PTY LTD	18236	LEVALBUTEROL HYDROCHLORIDE	2005-04-01	Active	II	N/A
28/03/2025	Aarti Pharmalabs	India	AARTI PHARMALABS LTD	20557	LEVALBUTEROL HCL	2007-05-23	Active	II	Complete	2013-03-07	2013-02-14

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Levalbuterol

Levalbuterol

ACCESS ALL DATA

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

20 API Suppliers

7 USDMF

2 EU WC

5 NDC API

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SOLUTION;INHALATION - EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

5 Actylis

EXCIPIENTS BY APPLICATIONS

3 Parenteral

2 Controlled & Modified Release

DIGITAL CONTENT

7 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

5 Regulatory FDF Prices

5 Annual Reports

MARKET PLACE

3 APIs

REF. STANDARDS & IMPURITIES

4 USP

10 Others

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