Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017863
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SORBITOL 3% IN PLASTIC CONTAINER SORBITOL 3GM/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
05/30/1980 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
08/01/2003 SUPPL-45 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17863slr045ltr.pdf
08/14/2001 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/2002 SUPPL-43 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17863slr043ltr.pdf
03/23/2004 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17863slr042ltr.pdf
11/24/1999 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

07/03/2002 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17863s040ltr.pdf
04/29/1997 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1993 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/08/1991 SUPPL-34 Labeling

Label is not available on this site.

03/26/1991 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1990 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1989 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1985 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-26 Labeling

Label is not available on this site.

06/13/1985 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1984 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1982 SUPPL-16 Labeling

Label is not available on this site.

12/22/1982 SUPPL-14 Labeling

Label is not available on this site.

12/22/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1981 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1981 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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