Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089454
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROTAMINE SULFATE PROTAMINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription None No 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
04/07/1987 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
06/11/2007 SUPPL-15 Labeling

Label is not available on this site.

03/29/2007 SUPPL-14 Labeling

Label is not available on this site.

12/05/2002 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

03/01/2002 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

05/23/1990 SUPPL-8 Labeling

Label is not available on this site.

10/27/1992 SUPPL-7 Labeling

Label is not available on this site.

02/22/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/25/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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