Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 009830
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESTINON PYRIDOSTIGMINE BROMIDE 5MG/ML INJECTABLE;INJECTION Prescription AP 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
10/02/1955 ORIG-1 Approval Type 3 - New Dosage Form 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
12/07/1999 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2001 SUPPL-12 Labeling

Label is not available on this site.

11/07/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2001 SUPPL-10 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/09829s9lbl.pdf
10/27/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/12/1990 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/16/1983 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1980 SUPPL-4 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
07/26/2001 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/09829s9lbl.pdf

MESTINON

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English