FDA Orange Book · active-ingredient family
Glyburide; metformin hydrochloride
Glyburide; metformin hydrochloride is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GLUCOVANCE · NDA 021178
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GLUCOVANCERLD×3 | BRISTOL MYERS SQUIBB | NDA 021178 | — | Jul 31, 2000 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GLYBURIDE AND METFORMIN HYDROCHLORIDE×3 | ZYDUS PHARMS | ANDA 206748 | AB | Feb 29, 2016 | |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE×3 | HERITAGE | ANDA 079009 | AB | Jun 03, 2009 | |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE×3 | AUROBINDO PHARMA | ANDA 077870 | AB | Nov 14, 2007 | |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE×3 | ACTAVIS ELIZABETH | ANDA 076716 | AB | Jun 28, 2005 | |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE×3 | TEVA | ANDA 076821 | — | Jan 27, 2005 | |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE×3 | IMPAX LABS INC | ANDA 076731 | — | Nov 19, 2004 | |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE×3 | IMPAX | ANDA 076345 | AB | Feb 18, 2004 |
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.
Glyburide; metformin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
