FDA Orange Book · active-ingredient family
Oxytetracycline hydrochloride; polymyxin b sulfate
Oxytetracycline hydrochloride; polymyxin b sulfate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TERRAMYCIN W/ POLYMYXIN B SULFATE · NDA 061015
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · ointment, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TERRAMYCIN W/ POLYMYXIN B SULFATE | CASPER PHARMA LLC | NDA 061015 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TERRAMYCIN W/ POLYMYXIN | PFIZER | ANDA 061841 | — | Approved Prior to Jan 1, 1982 | |
| TERRAMYCIN-POLYMYXIN | PFIZER | ANDA 061009 | — | 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; polymyxin b sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
