Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018924
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER AMINOPHYLLINE 100MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER AMINOPHYLLINE 200MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER AMINOPHYLLINE 400MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER AMINOPHYLLINE 500MG/100ML 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
12/12/1984 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/10/1998 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/02/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/13/1996 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/09/1996 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1992 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/02/1991 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/05/1992 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1990 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1992 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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