Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077756
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription AN No No
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription AN No No
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription AN No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/09/2008 ORIG-1 Approval

Label is not available on this site.

LEVALBUTEROL HYDROCHLORIDE

SOLUTION;INHALATION; EQ 0.021% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 207625 AUROBINDO PHARMA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 078171 CIPLA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 077756 IMPAX LABS INC
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 077800 MYLAN SPECIALITY LP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 203653 RITEDOSE CORP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 090297 TEVA PHARMS USA
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription Yes AN 020837 OAK PHARMS INC

SOLUTION;INHALATION; EQ 0.042% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 207625 AUROBINDO PHARMA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 078171 CIPLA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 077756 IMPAX LABS INC
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 077800 MYLAN SPECIALITY LP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 203653 RITEDOSE CORP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 090297 TEVA PHARMS USA
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription Yes AN 020837 OAK PHARMS INC

SOLUTION;INHALATION; EQ 0.0103% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 207625 AUROBINDO PHARMA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 078171 CIPLA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 077756 IMPAX LABS INC
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 077800 MYLAN SPECIALITY LP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 203653 RITEDOSE CORP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 090297 TEVA PHARMS USA
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription Yes AN 020837 OAK PHARMS INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English