Sirolimus

Prevents organ rejection. ANDA 201676, held by Zydus Pharms. Sirolimus.

As of Nov 15, 2026, ANDA 201676 (Sirolimus), held by Zydus Pharms, was first approved by FDA on Feb 15, 2023, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 15, 2023
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 months to 4 months after transplantation. Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation. Safety and efficacy of CsA withdrawal has not been established in high risk patients ( 1.1, 1.2, 14.3 ). Sirolimus is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Feb 15, 2023	Original application	Approved	None posted
Jan 8, 2014	Original application	Approved	None posted

Products

3 strengths and forms


Sirolimus1MG · tablet;oral	Sirolimus	Rx
Sirolimus2MG · tablet;oral	Sirolimus	Rx
Sirolimus0.5MG · tablet;oral	Sirolimus	Rx

All 14 submissions, including labeling and manufacturing supplements


Oct 27, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Feb 15, 2023	Original application	Approved	None posted
Feb 18, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Feb 18, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Feb 18, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Feb 18, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Feb 18, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Jan 8, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 201676
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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