TELMISARTAN | N020850 | BOEHRINGER INGELHEIM
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Unichem Pharmaceuticals (USA), Inc. FDA-2025-P-7054 Unichem Pharmaceuticals (USA), Inc. filed this citizen petition requesting that the FDA determine whether MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under NDA N020850, held by Boehringer Ingelheim, was voluntarily withdrawn for safety or effectiveness reasons. The petitioner seeks confirmation | 505(q) | 2025-12-15 | Open | Unichem Pharmaceuticals (USA) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.
Boehringer Ingelheim's MICARDIS (telmisartan) 80 mg product received Federal Register determination that it was not discontinued or withdrawn for safety or effectiveness reasons.
Old: 80MG
New: 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Boehringer Ingelheim's MICARDIS (telmisartan) 20 mg received Federal Register determination that the product was not discontinued or withdrawn for safety or effectiveness reasons.
Old: 20MG
New: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**