Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087601
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOPHYLLINE AMINOPHYLLINE 25MG/ML INJECTABLE;INJECTION 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
07/23/1982 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
12/01/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-10 Labeling

Label is not available on this site.

10/29/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/29/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/13/1990 SUPPL-7 Labeling

Label is not available on this site.

01/03/1990 SUPPL-6 Labeling

Label is not available on this site.

04/01/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/10/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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