Treats pulmonary arterial hypertension (WHO Group I). ANDA 78380, held by Teva Pharms. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 78380 (Sildenafil Citrate), held by Teva Pharms, was first approved by FDA on Jan 7, 2013, with 5 approved supplements and 0 published complete response letters.
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 7, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sildenafil CitrateEQ 20MG BASE · tablet;oral | Sildenafil Citrate | Discontinued |
| Feb 25, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 25, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 25, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 10, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 2, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 7, 2013 | Original application | Approved |
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
