FDA Orange Book · active-ingredient family
Demeclocycline hydrochloride
Demeclocycline hydrochloride is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DECLOMYCIN · NDA 050262
3
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, syrup, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DECLOMYCIN | LEDERLE | NDA 050262 | — | Approved Prior to Jan 1, 1982 | |
| DECLOMYCIN | LEDERLE | NDA 050257 | — | Approved Prior to Jan 1, 1982 | |
| DECLOMYCIN×3 | COREPHARMA | NDA 050261 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEMECLOCYCLINE HYDROCHLORIDE×2 | EPIC PHARMA LLC | ANDA 065447 | AB | Aug 18, 2015 | |
| DEMECLOCYCLINE HYDROCHLORIDE×2 | EPIC PHARMA LLC | ANDA 065389 | AB | Dec 01, 2008 | |
| DEMECLOCYCLINE HYDROCHLORIDE×2 | AMNEAL PHARM | ANDA 065425 | AB | Feb 27, 2008 | |
| DEMECLOCYCLINE HYDROCHLORIDE×2 | BARR | ANDA 065171 | — | Dec 13, 2004 | |
| DEMECLOCYCLINE HYDROCHLORIDE×2 | IMPAX LABS | ANDA 065094 | — | Mar 22, 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.
Demeclocycline hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
