Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017398
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REGONOL PYRIDOSTIGMINE BROMIDE 5MG/ML INJECTABLE;INJECTION Prescription AP 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
08/14/1973 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
05/18/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/22/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/21/2004 SUPPL-15 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17398s015ltr.pdf
10/17/2003 SUPPL-14 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17398scm014ltr.pdf
07/12/1999 SUPPL-13 Labeling

Label is not available on this site.

03/15/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/04/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/06/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/05/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/30/1988 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1987 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1999 SUPPL-5 Labeling

Label is not available on this site.

05/18/1982 SUPPL-4 Labeling

Label is not available on this site.

05/18/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/13/1980 SUPPL-2 Labeling

Label is not available on this site.

11/13/1980 SUPPL-1 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
09/21/2004 SUPPL-15 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17398s015lbl.pdf

REGONOL

INJECTABLE;INJECTION; 5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MESTINON PYRIDOSTIGMINE BROMIDE 5MG/ML INJECTABLE;INJECTION Prescription Yes AP 009830 BAUSCH
REGONOL PYRIDOSTIGMINE BROMIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 017398 SANDOZ INC

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