Treats symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for…. ANDA 76963, held by Innogenix. Pilocarpine Hydrochloride.
As of Nov 15, 2026, ANDA 76963 (Pilocarpine Hydrochloride), held by Innogenix, was first approved by FDA on Dec 22, 2004, with 4 approved supplements 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 |
|---|---|---|---|
| Dec 22, 2004 | Original application | Approved | None posted |
| Pilocarpine Hydrochloride5MG · tablet;oral | Pilocarpine Hydrochloride | Rx |
| Pilocarpine Hydrochloride7.5MG · tablet;oral | Pilocarpine Hydrochloride | Rx |
| Aug 26, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 16, 2008 | Supplement 5Labeling | Approved | None posted |
| Feb 27, 2007 | Supplement 1Labeling | Approved | None posted |
| Feb 27, 2007 | Supplement 2Manufacturing | Approved | None posted |
| Dec 22, 2004 | 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
