FDA Orange Book · active-ingredient family
Bacitracin
Bacitracin is approved in 10 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BACITRACIN | NASKA | ANDA 062857 | — | Nov 13, 1987 | |
| BACITRACIN | COMBE | ANDA 062799 | — | May 14, 1987 | |
| BACITRACIN | PHARMAFAIR | ANDA 062453 | — | Mar 28, 1984 | |
| BACITRACIN | PADDOCK LLC | ANDA 062456 | — | Jul 27, 1983 | |
| BACIGUENT | PHARMACIA AND UPJOHN | ANDA 060734 | — | Approved Prior to Jan 1, 1982 | |
| BACITRACIN | LILLY | ANDA 060687 | — | Approved Prior to Jan 1, 1982 | |
| BACITRACIN | PADAGIS US | ANDA 061212 | — | Approved Prior to Jan 1, 1982 | |
| BACITRACIN | PHARMADERM | ANDA 062158 | — | Approved Prior to Jan 1, 1982 | |
| BACI-RX | X GEN PHARMS | ANDA 061580 | — | Approved Prior to Jan 1, 1982 | |
| BACITRACIN | APOTHEKERNES | ANDA 061699 | — | 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.
Bacitracin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
