Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 020512
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER AMINO ACIDS 15% (15GM/100ML) INJECTABLE;INJECTION 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
08/30/1996 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
12/04/2003 SUPPL-7 Labeling

Label is not available on this site.

02/28/2001 SUPPL-5 Labeling

Label is not available on this site.

01/28/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/11/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/01/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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