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FDA ANDA · ANDA208804

ALBUTEROL

Sponsor: AMNEAL PHARMS CO

APPLICATION
ANDA208804
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-21
LATEST ACTION
2018-05-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 4MG BASE · TABLET · ORAL
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 2MG BASE · TABLET · ORAL

Approval history

2018-05-21UNKNOWN · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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