Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016772
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESECTISOL IN PLASTIC CONTAINER MANNITOL 5GM/100ML SOLUTION;IRRIGATION Prescription 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
02/10/1978 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
11/16/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/16/2003 SUPPL-30 Labeling

Label is not available on this site.

09/03/2002 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/10/2002 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/11/1990 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/19/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/30/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/27/1985 SUPPL-20 Labeling

Label is not available on this site.

03/05/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/03/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/17/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/24/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/22/1983 SUPPL-15 Labeling

Label is not available on this site.

11/06/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/27/1981 SUPPL-11 Labeling

Label is not available on this site.

10/27/1981 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/16/1980 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/15/1980 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/25/1979 SUPPL-7 Labeling

Label is not available on this site.

09/24/1979 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/20/1979 SUPPL-5 Labeling

Label is not available on this site.

04/26/1979 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/17/1979 SUPPL-3 Labeling

Label is not available on this site.

08/28/1978 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/07/1978 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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