Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050155
Company: PARKEDALE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROMYCETIN CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None Yes 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
02/20/1959 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
08/09/2005 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050155s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050155s039ltr.pdf
08/11/1999 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1999 SUPPL-37 Labeling

Label is not available on this site.

03/08/1999 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1994 SUPPL-35 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/16/1994 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1981 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/26/1980 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/10/1979 SUPPL-31 Labeling

Label is not available on this site.

12/07/1978 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1978 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/04/1978 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/10/1977 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/17/1977 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/16/1977 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/23/1977 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/11/1974 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/22/1975 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1973 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1966 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/25/1962 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1962 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1961 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1961 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1961 SUPPL-8 Labeling

Label is not available on this site.

04/21/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/22/1988 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/28/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2005 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050155s039lbl.pdf

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