FDA Orange Book · active-ingredient family
Albendazole
Albendazole is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ALBENZA · NDA 020666
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALBENZARLD | IMPAX LABS INC | NDA 020666 | — | Jun 11, 1996 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALBENDAZOLE | ALEMBIC | ANDA 215652 | AB | Sep 04, 2024 | |
| ALBENDAZOLE | DR REDDYS | ANDA 211034 | AB | Jan 26, 2021 | |
| ALBENDAZOLE | MSN | ANDA 213435 | AB | Jan 21, 2021 | |
| ALBENDAZOLE | CHARTWELL RX | ANDA 211636 | — | Jun 10, 2020 | |
| ALBENDAZOLE | ACTAVIS ELIZABETH | ANDA 208094 | AB | May 20, 2019 | |
| ALBENDAZOLE | EDENBRIDGE PHARMS | ANDA 211117 | AB | May 14, 2019 | |
| ALBENDAZOLE | ZYDUS PHARMS | ANDA 208979 | AB | Dec 14, 2018 | |
| ALBENDAZOLE | STRIDES PHARMA | ANDA 210011 | — | Dec 07, 2018 | |
| ALBENDAZOLE | CIPLA LTD | ANDA 210434 | — | Sep 21, 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.
Albendazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
