FDA Orange Book · active-ingredient family
Bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride 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:PYLERA · NDA 050786
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PYLERARLD | LABS JUVISE | NDA 050786 | AB | Sep 28, 2006 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | INGENUS PHARMS LLC | ANDA 217511 | AB | Jul 03, 2023 | |
| BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | PH HEALTH | ANDA 205770 | AB | Mar 06, 2023 |
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.
Bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
