Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017395
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTROPIN DOPAMINE HYDROCHLORIDE 40MG/ML INJECTABLE;INJECTION Discontinued None No No
INTROPIN DOPAMINE HYDROCHLORIDE 80MG/ML INJECTABLE;INJECTION Discontinued None No No
INTROPIN DOPAMINE HYDROCHLORIDE 160MG/ML INJECTABLE;INJECTION Discontinued None No 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
02/25/1974 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
11/05/2001 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1997 SUPPL-29 Labeling

Label is not available on this site.

05/05/1995 SUPPL-28 Labeling

Label is not available on this site.

10/07/1992 SUPPL-27 Labeling

Label is not available on this site.

04/12/1990 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/30/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/06/1983 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/02/1982 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/08/1982 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/15/1981 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1981 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/12/1981 SUPPL-19 Labeling

Label is not available on this site.

05/21/1981 SUPPL-18 Labeling

Label is not available on this site.

09/15/1981 SUPPL-17 Labeling

Label is not available on this site.

11/12/1981 SUPPL-16 Efficacy

Label is not available on this site.

11/14/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1980 SUPPL-14 Labeling

Label is not available on this site.

07/10/1980 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/10/1980 SUPPL-12 Labeling

Label is not available on this site.

07/10/1980 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1979 SUPPL-10 Labeling

Label is not available on this site.

06/11/1979 SUPPL-9 Labeling

Label is not available on this site.

06/11/1979 SUPPL-8 Labeling

Label is not available on this site.

08/24/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/20/1976 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/03/1976 SUPPL-4 Labeling

Label is not available on this site.

05/03/1976 SUPPL-3 Labeling

Label is not available on this site.

10/07/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1975 SUPPL-1 Labeling

Label is not available on this site.

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