FDA Orange Book · active-ingredient family
Ampicillin/ampicillin trihydrate; probenecid
Ampicillin/ampicillin trihydrate; probenecid is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRINCIPEN W/ PROBENECID · NDA 050488
2
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRINCIPEN W/ PROBENECID | APOTHECON | NDA 050488 | — | Approved Prior to Jan 1, 1982 | |
| POLYCILLIN-PRB | BRISTOL | NDA 050457 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRINCIPEN W/ PROBENECID | APOTHECON | ANDA 062150 | — | Approved Prior to Jan 1, 1982 | |
| POLYCILLIN-PRB | APOTHECON | ANDA 061898 | — | Approved Prior to Jan 1, 1982 | |
| PROBAMPACIN | COSETTE PHARMS NC | ANDA 061741 | — | 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.
Ampicillin/ampicillin trihydrate; probenecid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
