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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207820
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription AN No No
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/05/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2019 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

LEVALBUTEROL HYDROCHLORIDE

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 078171 CIPLA
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 207625 LUOXIN AUROVITAS
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 207820 SUN PHARM
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 HIKMA

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 078171 CIPLA
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 207625 LUOXIN AUROVITAS
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 207820 SUN PHARM
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 HIKMA

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 078171 CIPLA
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 207625 LUOXIN AUROVITAS
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 207820 SUN PHARM
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 HIKMA
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