Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017820
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOBUTREX DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML 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
07/18/1978 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
07/23/2002 SUPPL-37 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17820slr037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/17-820_Dobutrex.cfm
07/29/1998 SUPPL-36 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17820-s036_doubtrex.pdf
01/08/1997 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1996 SUPPL-33 Labeling

Label is not available on this site.

11/09/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/11/1996 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/30/1995 SUPPL-29 Labeling

Label is not available on this site.

04/20/1994 SUPPL-27 Labeling

Label is not available on this site.

02/09/1993 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1993 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1990 SUPPL-24 Labeling

Label is not available on this site.

04/26/1991 SUPPL-23 Labeling

Label is not available on this site.

12/07/1989 SUPPL-22 Labeling

Label is not available on this site.

04/18/1989 SUPPL-21 Labeling

Label is not available on this site.

06/23/1989 SUPPL-20 Labeling

Label is not available on this site.

04/21/1988 SUPPL-19 Labeling

Label is not available on this site.

05/27/1987 SUPPL-18 Labeling

Label is not available on this site.

01/21/1987 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1987 SUPPL-16 Labeling

Label is not available on this site.

01/21/1987 SUPPL-15 Labeling

Label is not available on this site.

03/07/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/07/1986 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1985 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1983 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/24/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1986 SUPPL-6 Labeling

Label is not available on this site.

06/17/1981 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/03/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1978 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/12/1978 SUPPL-1 Labeling

Label is not available on this site.

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