Treats symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for…. ANDA 77220, held by Lannett Co Inc. Pilocarpine Hydrochloride.
As of Nov 15, 2026, ANDA 77220 (Pilocarpine Hydrochloride), held by Lannett Co Inc, was first approved by FDA on Oct 14, 2005, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE: Pilocarpine hydrochloride tablets, USP 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 |
|---|---|---|---|
| Oct 14, 2005 | Original application | Approved | None posted |
| Pilocarpine Hydrochloride5MG · tablet;oral | Pilocarpine Hydrochloride | Rx |
| Pilocarpine Hydrochloride7.5MG · tablet;oral | Pilocarpine Hydrochloride | Rx |
| May 6, 2009 | Supplement 4Labeling | Approved | None posted |
| Oct 14, 2005 | 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
