Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018986
Company: MERIDIAN MEDCL TECHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRALIDOXIME CHLORIDE PRALIDOXIME CHLORIDE 300MG/ML 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
04/26/1983 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/1983-018986ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2015 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

08/21/2014 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

12/31/2013 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

10/24/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/01/2002 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/25/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/23/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/02/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/2001 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/27/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/10/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/08/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/21/1998 SUPPL-10 Labeling

Label is not available on this site.

03/06/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/23/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/18/1991 SUPPL-7 Labeling

Label is not available on this site.

07/31/1986 SUPPL-5 Labeling

Label is not available on this site.

03/21/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1986 SUPPL-2 Labeling

Label is not available on this site.

02/06/1985 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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