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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210948
Company: AIZANT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription AB No No
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription AB 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
03/15/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ALBUTEROL SULFATE

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription No AB 210948 AIZANT
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription No AB 208804 AMNEAL PHARMS CO
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription No AB 072894 MYLAN
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription No AB 207046 RISING
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription No AB 072637 SUN PHARM INDUSTRIES
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription No AB 211397 VIRTUS PHARM
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription No AB 208884 ZYDUS PHARMS

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription No AB 210948 AIZANT
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription No AB 208804 AMNEAL PHARMS CO
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription No AB 072894 MYLAN
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription No AB 207046 RISING
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription No AB 072637 SUN PHARM INDUSTRIES
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription No AB 211397 VIRTUS PHARM
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription No AB 208884 ZYDUS PHARMS
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