Treats parenchymal neurocysticercosis due to active lesions caused by larval forms of the…. ANDA 211117, held by Edenbridge Pharms. Albendazole.
As of Nov 15, 2026, ANDA 211117 (Albendazole), held by Edenbridge Pharms, was first approved by FDA on May 14, 2019, with 0 approved supplements and 0 published complete response letters.
Albendazole Tablets is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus. 1.1 Neurocysticercosis Albendazole Tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 14, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Albendazole200MG · tablet;oral | Albendazole | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
