FDA Orange Book · active-ingredient family
Codeine sulfate
Codeine sulfate is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CODEINE SULFATE · NDA 022402
2
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CODEINE SULFATERLD×3 | HIKMA | NDA 022402 | AB | Jul 16, 2009 | |
| CODEINE SULFATE | HIKMA | NDA 202245 | — | Jun 30, 2011 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CODEINE SULFATE×3 | LANNETT CO INC | ANDA 203046 | AB | Jun 13, 2014 |
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.
Codeine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
