Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070799
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE 40MG/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
02/11/1987 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2001 SUPPL-11 Labeling

Label is not available on this site.

11/07/1997 SUPPL-10 Labeling

Label is not available on this site.

01/09/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-8 Labeling

Label is not available on this site.

02/28/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/30/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/27/1992 SUPPL-5 Labeling

Label is not available on this site.

08/26/1992 SUPPL-4 Labeling

Label is not available on this site.

06/30/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/05/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/30/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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