Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011145
Company: OAK PHARMS AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIURIL CHLOROTHIAZIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
DIURIL CHLOROTHIAZIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
DIURIL CHLOROTHIAZIDE SODIUM EQ 500MG 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
09/04/1958 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2013 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

08/10/2005 SUPPL-93 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011145s093,011870s037ltr.pdf
10/22/2004 SUPPL-92 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s092ltr.pdf
09/23/2004 SUPPL-91 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf
09/23/2004 SUPPL-90 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf
11/08/2002 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

09/08/1999 SUPPL-88 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/05/1997 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1997 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-85 Labeling

Label is not available on this site.

11/29/1995 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

05/23/1995 SUPPL-83 Labeling

Label is not available on this site.

05/23/1995 SUPPL-82 Labeling

Label is not available on this site.

03/16/1994 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

03/31/1994 SUPPL-80 Labeling

Label is not available on this site.

03/02/1993 SUPPL-79 Labeling

Label is not available on this site.

02/16/1994 SUPPL-78 Labeling

Label is not available on this site.

05/30/1989 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

03/02/1993 SUPPL-74 Labeling

Label is not available on this site.

03/02/1993 SUPPL-73 Labeling

Label is not available on this site.

12/08/1986 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

01/14/1986 SUPPL-64 Labeling

Label is not available on this site.

01/13/1986 SUPPL-63 Labeling

Label is not available on this site.

11/04/1985 SUPPL-62 Labeling

Label is not available on this site.

10/11/1984 SUPPL-61 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1985 SUPPL-60 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/11/1984 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/24/1984 SUPPL-58 Labeling

Label is not available on this site.

08/28/1984 SUPPL-57 Labeling

Label is not available on this site.

08/30/1984 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/06/1984 SUPPL-55 Labeling

Label is not available on this site.

03/06/1984 SUPPL-54 Labeling

Label is not available on this site.

03/01/1983 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1982 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

07/14/1981 SUPPL-51 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1981 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

06/17/1981 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/08/1987 SUPPL-48 Labeling

Label is not available on this site.

01/13/1981 SUPPL-46 Labeling

Label is not available on this site.

01/13/1981 SUPPL-45 Labeling

Label is not available on this site.

11/14/1980 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/31/1979 SUPPL-43 Labeling

Label is not available on this site.

10/31/1979 SUPPL-42 Labeling

Label is not available on this site.

07/13/1979 SUPPL-41 Labeling

Label is not available on this site.

10/31/1979 SUPPL-40 Labeling

Label is not available on this site.

10/31/1979 SUPPL-39 Labeling

Label is not available on this site.

03/09/1979 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1979 SUPPL-37 Labeling

Label is not available on this site.

10/31/1979 SUPPL-36 Labeling

Label is not available on this site.

07/31/1978 SUPPL-35 Labeling

Label is not available on this site.

02/15/1978 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/02/1977 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/31/1979 SUPPL-31 Labeling

Label is not available on this site.

01/12/1976 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1975 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1975 SUPPL-20 Unspecified

Label is not available on this site.

03/27/1975 SUPPL-19 Unspecified

Label is not available on this site.

DIURIL

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202561 AM REGENT
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090896 FRESENIUS KABI USA
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202493 MYLAN INSTITUTIONAL
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202462 SAGENT PHARMS INC
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091546 SUN PHARM
DIURIL CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 011145 OAK PHARMS AKORN

DIURIL

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202561 AM REGENT
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090896 FRESENIUS KABI USA
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202493 MYLAN INSTITUTIONAL
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202462 SAGENT PHARMS INC
CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091546 SUN PHARM
DIURIL CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 011145 OAK PHARMS AKORN

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