Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050095
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPASTAT SULFATE CAPREOMYCIN SULFATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
06/02/1971 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
01/16/2019 SUPPL-72 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050095s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050095Orig1s072ltr.pdf
07/24/2008 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050095s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050095s062ltr.pdf
06/11/2003 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50095slr044_capastat_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50095slr044ltr.pdf
10/05/2001 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1995 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-41 Labeling

Label is not available on this site.

08/12/1987 SUPPL-38 Labeling

Label is not available on this site.

07/08/1987 SUPPL-37 Labeling

Label is not available on this site.

05/26/1987 SUPPL-36 Labeling

Label is not available on this site.

03/06/1987 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1985 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/26/1983 SUPPL-33 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/23/1983 SUPPL-32 Labeling

Label is not available on this site.

08/05/1983 SUPPL-31 Labeling

Label is not available on this site.

08/31/1982 SUPPL-30 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/12/1982 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/29/1981 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/11/1981 SUPPL-27 Labeling

Label is not available on this site.

03/04/1981 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/11/1981 SUPPL-25 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/03/1980 SUPPL-24 Labeling

Label is not available on this site.

01/25/1980 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/03/1978 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/21/1977 SUPPL-21 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/12/1977 SUPPL-20 Labeling

Label is not available on this site.

12/03/1976 SUPPL-19 Labeling

Label is not available on this site.

09/14/1976 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/28/1975 SUPPL-17 Labeling

Label is not available on this site.

09/23/1975 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/20/1974 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/28/1973 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/18/1973 SUPPL-13 Labeling

Label is not available on this site.

08/29/1972 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/25/1972 SUPPL-11 Labeling

Label is not available on this site.

12/20/1971 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/12/1988 SUPPL-9 Labeling

Label is not available on this site.

05/26/1987 SUPPL-8 Labeling

Label is not available on this site.

07/08/1987 SUPPL-7 Labeling

Label is not available on this site.

05/26/1987 SUPPL-6 Labeling

Label is not available on this site.

12/09/1986 SUPPL-5 Labeling

Label is not available on this site.

01/18/1985 SUPPL-4 Labeling

Label is not available on this site.

09/26/1983 SUPPL-3 Labeling

Label is not available on this site.

08/23/1983 SUPPL-2 Labeling

Label is not available on this site.

08/05/1983 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/16/2019 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050095s072lbl.pdf
07/24/2008 SUPPL-62 Labeling Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050095s062lbl.pdf
06/11/2003 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50095slr044_capastat_lbl.pdf

CAPASTAT SULFATE

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAPASTAT SULFATE CAPREOMYCIN SULFATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050095 AKORN
CAPREOMYCIN SULFATE CAPREOMYCIN SULFATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204796 HISUN PHARM HANGZHOU
CAPREOMYCIN SULFATE CAPREOMYCIN SULFATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202634 MYLAN LABS LTD

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