Sildenafil Citrate

Treats pulmonary arterial hypertension (WHO Group I). ANDA 203814, held by Macleods Pharms. Sildenafil Citrate.

As of Nov 15, 2026, ANDA 203814 (Sildenafil Citrate), held by Macleods Pharms, was first approved by FDA on Dec 17, 2013, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 17, 2013
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Dec 17, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sildenafil CitrateEQ 20MG BASE · tablet;oral	Sildenafil Citrate	Rx

All 9 submissions, including labeling and manufacturing supplements


Jun 30, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Jun 30, 2025	Supplement 27Labeling · Standard review	Approved	None posted
Jun 30, 2025	Supplement 29Labeling · Standard review	Approved	None posted
Apr 23, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Apr 23, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Apr 23, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Oct 26, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Apr 2, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Dec 17, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 203814
Drugs@FDA: Overview at FDA
Company: Macleods Pharmaceuticals

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