Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014879
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOPRAM DOXAPRAM HYDROCHLORIDE 20MG/ML 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
06/23/1965 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/17/2005 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14879s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14879s044ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/014879_S044_Dopram Injection_APPROVAL_ PACKAGE.pdf
04/16/2004 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14879slr040_dopram_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14879slr040ltr.pdf
03/29/2006 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014879s037ltr.pdf
08/23/2001 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/14879s36ltr.pdf
02/13/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/13/1989 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1988 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1987 SUPPL-31 Labeling

Label is not available on this site.

01/14/1987 SUPPL-30 Labeling

Label is not available on this site.

06/18/1986 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1986 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1983 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1985 SUPPL-25 Labeling

Label is not available on this site.

03/04/1982 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/06/1982 SUPPL-23 Labeling

Label is not available on this site.

08/06/1982 SUPPL-22 Unspecified

Label is not available on this site.

08/06/1982 SUPPL-21 Labeling

Label is not available on this site.

08/06/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1978 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1978 SUPPL-16 Labeling

Label is not available on this site.

02/15/1979 SUPPL-15 Labeling

Label is not available on this site.

02/15/1979 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/20/1977 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/06/1977 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1976 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1976 SUPPL-7 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/17/2005 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14879s044lbl.pdf
04/16/2004 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14879slr040_dopram_lbl.pdf

DOPRAM

INJECTABLE;INJECTION; 20MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOPRAM DOXAPRAM HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription Yes AP 014879 HIKMA
DOXAPRAM HYDROCHLORIDE DOXAPRAM HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 076266 ATHENEX INC

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