FDA Orange Book · active-ingredient family
Bismuth subsalicylate; metronidazole; tetracycline hydrochloride
Bismuth subsalicylate; metronidazole; tetracycline hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HELIDAC · NDA 050719
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, chewable, tablet, capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HELIDACRLD | CASPER PHARMA LLC | NDA 050719 | — | Aug 15, 1996 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | AILEX PHARMS LLC | ANDA 202584 | — | Nov 30, 2018 |
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 subsalicylate; metronidazole; tetracycline hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
