Treats symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for…. ANDA 212377, held by Quagen. Pilocarpine Hydrochloride.
As of Nov 15, 2026, ANDA 212377 (Pilocarpine Hydrochloride), held by Quagen, was first approved by FDA on Aug 13, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Pilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 13, 2019 | Original application | Approved | None posted |
| Pilocarpine Hydrochloride5MG · tablet;oral | Pilocarpine Hydrochloride | Rx |
| Pilocarpine Hydrochloride7.5MG · tablet;oral | Pilocarpine Hydrochloride | 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
