ANDA 77283, held by Gland Pharma Ltd. Adenosine.
As of Nov 14, 2026, ANDA 77283 (Adenosine), held by Gland Pharma Ltd, was first approved by FDA on Jun 14, 2007, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Adenosine Injection, USP is indicated for the following: Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration. It is important to be sure the adenosine solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION ). Adenosine does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adenosine3MG/ML · injectable;injection | Adenosine | Rx |
| Nov 20, 2009 | Supplement 6Labeling | Approved | None posted |
| Apr 14, 2008 | Supplement 4Labeling | Approved | None posted |
| Jan 14, 2008 | Supplement 2Labeling | Approved | None posted |
| Jun 14, 2007 | 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
