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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050182
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERYTHROCIN ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
ERYTHROCIN ERYTHROMYCIN LACTOBIONATE EQ 1GM BASE/VIAL 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
06/25/1964 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
09/16/2004 SUPPL-125 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50609s019,50182s125ltr.pdf
12/13/2002 SUPPL-124 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/29/2002 SUPPL-123 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/2002 SUPPL-122 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50182s122ltr.pdf
04/23/1999 SUPPL-121 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1997 SUPPL-119 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1996 SUPPL-118 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/06/1983 SUPPL-117 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/23/1982 SUPPL-116 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1982 SUPPL-115 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1982 SUPPL-114 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1981 SUPPL-113 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/1981 SUPPL-112 Labeling

Label is not available on this site.

09/16/1981 SUPPL-111 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1981 SUPPL-110 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1981 SUPPL-109 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1981 SUPPL-108 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1981 SUPPL-107 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1981 SUPPL-106 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1981 SUPPL-105 Labeling

Label is not available on this site.

12/17/1980 SUPPL-104 Labeling

Label is not available on this site.

10/21/1980 SUPPL-102 Labeling

Label is not available on this site.

10/21/1980 SUPPL-101 Labeling

Label is not available on this site.

09/23/1980 SUPPL-100 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1980 SUPPL-99 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1980 SUPPL-98 Labeling

Label is not available on this site.

07/23/1980 SUPPL-97 Labeling

Label is not available on this site.

07/17/1980 SUPPL-96 Labeling

Label is not available on this site.

07/15/1980 SUPPL-95 Labeling

Label is not available on this site.

06/26/1980 SUPPL-94 Labeling

Label is not available on this site.

05/23/1980 SUPPL-93 Labeling

Label is not available on this site.

05/21/1980 SUPPL-92 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1980 SUPPL-91 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1980 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1980 SUPPL-89 Labeling

Label is not available on this site.

05/06/1980 SUPPL-88 Labeling

Label is not available on this site.

05/07/1980 SUPPL-87 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/25/1980 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1980 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1980 SUPPL-84 Labeling

Label is not available on this site.

03/25/1980 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1980 SUPPL-82 Labeling

Label is not available on this site.

03/12/1980 SUPPL-81 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1980 SUPPL-80 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/14/1980 SUPPL-79 Labeling

Label is not available on this site.

01/04/1980 SUPPL-78 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/16/1980 SUPPL-77 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/17/1979 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1979 SUPPL-75 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/06/1979 SUPPL-74 Labeling

Label is not available on this site.

11/06/1979 SUPPL-73 Labeling

Label is not available on this site.

09/18/1979 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1979 SUPPL-71 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/22/1979 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1979 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1979 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1979 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1979 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1979 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1979 SUPPL-64 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/13/1979 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1979 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1979 SUPPL-61 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/20/1979 SUPPL-60 Labeling

Label is not available on this site.

03/29/1979 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/07/1979 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1979 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1979 SUPPL-56 Labeling

Label is not available on this site.

01/08/1979 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1978 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1978 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1978 SUPPL-52 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/30/1978 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1978 SUPPL-49 Labeling

Label is not available on this site.

06/07/1978 SUPPL-48 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/25/1978 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1977 SUPPL-46 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/10/1977 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1975 SUPPL-43 Labeling

Label is not available on this site.

05/17/1972 SUPPL-42 Labeling

Label is not available on this site.

05/10/1974 SUPPL-41 Efficacy-New Indication

Label is not available on this site.

11/19/1971 SUPPL-40 Labeling

Label is not available on this site.

04/27/1971 SUPPL-39 Labeling

Label is not available on this site.

09/19/1968 SUPPL-38 Labeling

Label is not available on this site.

06/15/1967 SUPPL-37 Labeling

Label is not available on this site.

04/18/1967 SUPPL-36 Labeling

Label is not available on this site.

12/30/1966 SUPPL-35 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/16/1966 SUPPL-34 Labeling

Label is not available on this site.

05/31/1966 SUPPL-33 Labeling

Label is not available on this site.

01/14/1966 SUPPL-32 Labeling

Label is not available on this site.

10/08/1965 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/15/1965 SUPPL-30 Labeling

Label is not available on this site.

10/05/1965 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1993 SUPPL-28 Labeling

Label is not available on this site.

10/11/1996 SUPPL-27 Labeling

Label is not available on this site.

12/05/1991 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/03/1991 SUPPL-23 Labeling

Label is not available on this site.

11/30/1988 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1987 SUPPL-21 Labeling

Label is not available on this site.

05/11/1965 SUPPL-20 Labeling

Label is not available on this site.

05/04/1965 SUPPL-19 Labeling

Label is not available on this site.

02/10/1965 SUPPL-18 Labeling

Label is not available on this site.

10/27/1964 SUPPL-16 Labeling

Label is not available on this site.

10/26/1964 SUPPL-15 Labeling

Label is not available on this site.

05/16/1984 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1984 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1983 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/09/1983 SUPPL-11 Labeling

Label is not available on this site.

11/01/1983 SUPPL-10 Labeling

Label is not available on this site.

07/22/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/02/1983 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1983 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1964 SUPPL-6 Labeling

Label is not available on this site.

08/20/1964 SUPPL-5 Labeling

Label is not available on this site.

08/05/1964 SUPPL-4 Labeling

Label is not available on this site.

07/17/1964 SUPPL-3 Labeling

Label is not available on this site.

10/08/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1964 SUPPL-1 Labeling

Label is not available on this site.

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