FDA Orange Book · active-ingredient family
Mefenamic acid
Mefenamic acid is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PONSTEL · NDA 015034
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PONSTELRLD | AVION PHARMS | NDA 015034 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEFENAMIC ACID | CHARTWELL RX | ANDA 209209 | — | Sep 18, 2020 | |
| MEFENAMIC ACID | AJENAT PHARMS | ANDA 091608 | AB | Jun 02, 2014 | |
| MEFENAMIC ACID | MPP PHARMA | ANDA 090359 | — | Feb 05, 2013 | |
| MEFENAMIC ACID | LUPIN LTD | ANDA 091322 | AB | Jul 22, 2011 | |
| MEFENAMIC ACID | MICRO LABS | ANDA 090562 | AB | Nov 19, 2010 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Mefenamic acid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
