Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017633
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYCINE 1.5% IN PLASTIC CONTAINER GLYCINE 1.5GM/100ML SOLUTION;IRRIGATION 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
05/25/1976 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
09/03/1999 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

02/10/1998 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

09/24/1999 SUPPL-46 Labeling

Label is not available on this site.

05/05/1997 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

08/30/1996 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

12/30/1993 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/30/1992 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/01/1990 SUPPL-39 Labeling

Label is not available on this site.

08/24/1993 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/25/1988 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/18/1986 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/25/1984 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/01/1984 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/10/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/02/1981 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/06/1981 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/29/1981 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/17/1983 SUPPL-24 Labeling

Label is not available on this site.

10/01/1980 SUPPL-23 Labeling

Label is not available on this site.

09/08/1980 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/27/1980 SUPPL-21 Labeling

Label is not available on this site.

06/06/1980 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/23/1980 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/21/1981 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/20/1980 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/04/1979 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/18/1979 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/31/1979 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/18/1979 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/01/1979 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/29/1978 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/17/1978 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/05/1977 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/05/1977 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/25/1977 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/28/1977 SUPPL-3 Labeling

Label is not available on this site.

08/18/1976 SUPPL-2 Labeling

Label is not available on this site.

07/21/1977 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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