Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006823
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AQUASOL A VITAMIN A PALMITATE EQ 50,000 UNITS BASE/ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/18/1949 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/11/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/01/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/27/1998 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/09/2000 SUPPL-14 Labeling

Label is not available on this site.

02/02/1993 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/1990 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/21/1989 SUPPL-11 Labeling

Label is not available on this site.

09/19/1984 SUPPL-9 Labeling

Label is not available on this site.

09/19/1984 SUPPL-8 Labeling

Label is not available on this site.

10/03/1983 SUPPL-6 Labeling

Label is not available on this site.

04/20/1982 SUPPL-5 Labeling

Label is not available on this site.

01/30/1980 SUPPL-4 Labeling

Label is not available on this site.

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