Treats pulmonary arterial hypertension (PAH) (WHO Group I). ANDA 204883, held by Rubicon Research. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 204883 (Sildenafil Citrate), held by Rubicon Research, was first approved by FDA on Jun 20, 2016, with 4 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Sildenafil tablets are phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. ( 1, 14 ) Sildenafil tablets are
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sildenafil CitrateEQ 20MG BASE · tablet;oral | Sildenafil Citrate | Rx |
| Feb 19, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 19, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 19, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 19, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 20, 2016 | 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
