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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013055
Company: PAI HOLDINGS PHARM

Products on NDA 013055

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORFLEX	ORPHENADRINE CITRATE	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 013055

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/1960	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2008	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013055s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013055s021ltr.pdf
06/04/2002	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
06/06/2001	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/22/2000	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
09/24/1992	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
09/03/1991	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/22/1985	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/29/1978	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/24/1978	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
11/03/1975	SUPPL-8	Labeling		Label is not available on this site.

Labels for NDA 013055

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2008	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013055s021lbl.pdf

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