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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017398
Company: SANDOZ

Products on NDA 017398

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017398

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
04/05/2021	SUPPL-25	Labeling-Package Insert, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017398Orig1s025ltr.pdf
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.

Labels for NDA 017398

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

Therapeutic Equivalents for NDA 017398

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

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