Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 007942
Company: FOREST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUS-PHRINE SULFITE FREE EPINEPHRINE 5MG/ML INJECTABLE;INJECTION Discontinued None No No
SUS-PHRINE SULFITE FREE EPINEPHRINE 1.5MG/AMP 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
06/08/1951 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
10/07/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1999 SUPPL-16 Labeling

Label is not available on this site.

02/08/1995 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1993 SUPPL-14 Labeling

Label is not available on this site.

12/07/2007 SUPPL-12 Labeling

Label is not available on this site.

01/19/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/07/2007 SUPPL-9 Labeling

Label is not available on this site.

10/16/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1983 SUPPL-5 Labeling

Label is not available on this site.

10/26/1983 SUPPL-3 Labeling

Label is not available on this site.

10/26/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-1 Efficacy

Label is not available on this site.

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