FDA Orange Book · active-ingredient family
Cefdinir
Cefdinir is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OMNICEF · NDA 050739
2
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OMNICEFRLD | ABBVIE | NDA 050739 | — | Dec 04, 1997 | |
| OMNICEFRLD×2 | ABBVIE | NDA 050749 | — | Dec 04, 1997 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFDINIR | ALKEM LABS LTD | ANDA 210220 | AB | Feb 19, 2021 | |
| CEFDINIR×2 | ALKEM LABS LTD | ANDA 210534 | AB | Feb 19, 2021 | |
| CEFDINIR | AUROBINDO PHARMA | ANDA 065434 | AB | Jan 07, 2008 | |
| CEFDINIR×2 | AUROBINDO PHARMA | ANDA 065473 | AB | Dec 14, 2007 | |
| CEFDINIR | ANDA REPOSITORY | ANDA 065418 | AB | Jul 18, 2007 | |
| CEFDINIR×2 | ANDA REPOSITORY | ANDA 065429 | AB | Jul 18, 2007 | |
| CEFDINIR | TEVA PHARMS | ANDA 065368 | AB | May 09, 2007 | |
| CEFDINIR×2 | TEVA PHARMS | ANDA 065332 | AB | May 04, 2007 | |
| CEFDINIR | CHARTWELL RX | ANDA 065330 | AB | Apr 06, 2007 | |
| CEFDINIR×2 | CHARTWELL RX | ANDA 065337 | AB | Apr 06, 2007 | |
| CEFDINIR×2 | LUPIN | ANDA 065259 | AB | May 31, 2006 | |
| CEFDINIR | LUPIN | ANDA 065264 | AB | May 19, 2006 |
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.
Cefdinir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
