Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072860
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Discontinued None No No
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;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
12/20/1989 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/1993 SUPPL-5 Labeling

Label is not available on this site.

12/30/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/22/1993 SUPPL-3 Labeling

Label is not available on this site.

11/23/1990 SUPPL-2 Labeling

Label is not available on this site.

08/31/1990 SUPPL-1 Labeling

Label is not available on this site.

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