Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050356
Company: ENDO PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLY-MYCIN S COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML SUSPENSION/DROPS;OTIC 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
05/17/1962 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
01/05/2019 SUPPL-59 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050356s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050356Orig1s059ltr.pdf
03/29/2016 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

12/06/2013 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/02/2009 SUPPL-50 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050356s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050356s050ltr.pdf
12/05/2001 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/27/2001 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

04/23/1997 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2002 SUPPL-45 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50356s45ltr.pdf
08/02/1994 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1997 SUPPL-43 Labeling

Label is not available on this site.

08/03/1982 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/05/1982 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/18/1982 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1981 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/15/1980 SUPPL-38 Labeling

Label is not available on this site.

10/17/1979 SUPPL-37 Labeling

Label is not available on this site.

07/19/1978 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/18/1976 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/16/1972 SUPPL-34 Labeling

Label is not available on this site.

11/20/1968 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/24/1967 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1967 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1967 SUPPL-29 Labeling

Label is not available on this site.

04/18/1967 SUPPL-28 Labeling

Label is not available on this site.

03/08/1967 SUPPL-27 Labeling

Label is not available on this site.

01/31/1967 SUPPL-26 Labeling

Label is not available on this site.

01/31/1967 SUPPL-25 Labeling

Label is not available on this site.

12/21/1966 SUPPL-24 Labeling

Label is not available on this site.

10/31/1966 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1966 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1966 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/22/1966 SUPPL-20 Labeling

Label is not available on this site.

01/07/1966 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/15/1965 SUPPL-17 Labeling

Label is not available on this site.

12/14/1965 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/27/1965 SUPPL-15 Labeling

Label is not available on this site.

04/16/1965 SUPPL-14 Labeling

Label is not available on this site.

05/26/1965 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/20/1964 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1964 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1964 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/16/1964 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/17/1986 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/17/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/23/1984 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/13/1983 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/28/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/05/2019 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050356s059lbl.pdf
01/05/2019 SUPPL-59 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050356s059lbl.pdf
06/02/2009 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050356s050lbl.pdf

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