ANDA 89361, held by Pioneer Pharms. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 89361 (Dicyclomine Hydrochloride), held by Pioneer Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride10MG ยท capsule;oral | Dicyclomine Hydrochloride | Discontinued |
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
