FDA Orange Book · active-ingredient family
Metformin hydrochloride; repaglinide
Metformin hydrochloride; repaglinide is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRANDIMET · NDA 022386
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRANDIMETRLD×2 | NOVO NORDISK INC | NDA 022386 | — | Jun 23, 2008 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REPAGLINIDE AND METFORMIN HYDROCHLORIDE×2 | LUPIN | ANDA 200624 | — | Jul 15, 2015 |
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.
Metformin hydrochloride; repaglinide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
