FDA Orange Book · active-ingredient family
Oxytetracycline hydrochloride
Oxytetracycline hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TERRAMYCIN · NDA 050286
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TERRAMYCIN×2 | PFIZER | NDA 050286 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXY-KESSO-TETRA | FERRANTE | ANDA 060179 | — | Approved Prior to Jan 1, 1982 | |
| OXYTETRACYCLINE HYDROCHLORIDE | HIKMA | ANDA 060770 | — | Approved Prior to Jan 1, 1982 | |
| OXYTETRACYCLINE HYDROCHLORIDE | IMPAX LABS | ANDA 060760 | — | Approved Prior to Jan 1, 1982 | |
| OXYTETRACYCLINE HYDROCHLORIDE | PROTER | ANDA 060869 | — | Approved Prior to Jan 1, 1982 | |
| OXYTETRACYCLINE HYDROCHLORIDE | PUREPAC PHARM | ANDA 060634 | — | Approved Prior to Jan 1, 1982 | |
| TERRAMYCIN×2 | PFIZER | ANDA 060586 | — | 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.
Oxytetracycline hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
