Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 010401
Company: FHTA

Products on NDA 010401

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYSOLINE	PRIMIDONE	250MG/5ML	SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010401

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/05/1956	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
12/20/2000	SUPPL-13	Manufacturing (CMC)-Expiration Date	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/010401s013lbl.pdf
04/10/2000	SUPPL-12	Labeling		Label is not available on this site.
04/13/1995	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/25/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/28/1982	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 010401

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2000	SUPPL-13	Manufacturing (CMC)-Expiration Date	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/010401s013lbl.pdf