Treats parenchymal neurocysticercosis due to active lesions caused by larval forms of the…. ANDA 208094, held by Actavis Elizabeth. Albendazole.
As of Nov 15, 2026, ANDA 208094 (Albendazole), held by Actavis Elizabeth, was first approved by FDA on May 20, 2019, with 1 approved supplement and 0 published complete response letters.
Albendazole tablets are 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 20, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Albendazole200MG · tablet;oral | Albendazole | Rx |
| Nov 13, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 20, 2019 | Original application | Approved | None posted |
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
