Application 015034

Type: NDA
Sponsor: SHIONOGI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	PONSTEL	MEFENAMIC ACID	CAPSULE;ORAL	250MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59630-400	Ponstel	Mefenamic Acid	SHIONOGI INC.	NDA	Current
66993-070	Mefenamic Acid	Mefenamic Acid	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84627	SUPPL	2026-01-27
84626	SUPPL	2026-01-02
84625	SUPPL	2026-01-02
80337	SUPPL	2024-11-25
80288	SUPPL	2024-11-22
67228	SUPPL	2021-04-29
67227	SUPPL	2021-04-29
67219	SUPPL	2021-04-29
10853	SUPPL	2016-05-11
394	SUPPL	2016-05-11
43588	ORIG	2009-11-20
40700	SUPPL	2008-08-11
20048	SUPPL	2008-08-04
393	SUPPL	2008-03-17
33130	SUPPL	2008-03-07
33129	SUPPL	2006-01-20
392	SUPPL	2006-01-20