Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014134
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROTOPAM CHLORIDE PRALIDOXIME CHLORIDE 1GM/VIAL INJECTABLE;INJECTION Prescription None Yes 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
03/11/1964 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/03/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/30/2012 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/04/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/27/2002 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/14134s24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14134slr024ltr.pdf
05/06/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/2010 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/014134s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/014134s022ltr.pdf
12/11/1995 SUPPL-21 Labeling

Label is not available on this site.

04/28/1992 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/15/1991 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1986 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1985 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1985 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1985 SUPPL-13 Labeling

Label is not available on this site.

05/20/1985 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1981 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1981 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/1978 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/11/1974 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/08/2010 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/014134s022lbl.pdf
09/27/2002 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/14134s24lbl.pdf

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