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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078092
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None 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
01/29/2007 ORIG-1 Approval

Label is not available on this site.

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