FDA Orange Book · active-ingredient family
Griseofulvin, microsize
Griseofulvin, microsize is approved in 9 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GRISEOFULVIN×2 | SANDOZ | ANDA 091592 | AB | Aug 07, 2013 | |
| GRISEOFULVIN | SIGMAPHARM LABS LLC | ANDA 202482 | AB | Oct 22, 2012 | |
| GRISEOFULVIN | COSETTE PHARMS NC | ANDA 065438 | AB | Oct 08, 2010 | |
| GRISEOFULVIN | CIPLA | ANDA 065354 | AB | Sep 10, 2007 | |
| GRISEOFULVIN | ACTAVIS MID ATLANTIC | ANDA 065394 | AB | Jul 06, 2007 | |
| GRISEOFULVIN | CHARTWELL RX | ANDA 065200 | AB | Mar 02, 2005 | |
| GRIFULVIN V | VALEANT LUXEMBOURG | ANDA 062483 | — | Jan 26, 1984 | |
| FULVICIN-U/F×2 | CHARTWELL RX | ANDA 060569 | AB | Approved Prior to Jan 1, 1982 | |
| GRIFULVIN V | VALEANT LUXEMBOURG | ANDA 062279 | — | Approved Prior to Jan 1, 1982 |
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.
Griseofulvin, microsize — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
