AZELAIC ACID | N021470 | LEO PHARMA AS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
FDA/CDER Response to Intendis, Inc. (Foley & Lardner LLP) - Partial Pettion A... FDA-2011-P-0227 Intendis, Inc., represented by Foley & Lardner LLP, filed a citizen petition requesting that FDA issue a timely response to Intendis' August 2010 comments on the May 2010 Draft Guidance on Azelaic Acid, stay approval of any pending ANDAs or 505(b)(2) NDAs for azelaic acid products based on the draft | 505(q) Stay Request | 2012-06-22 | Partially Denied | — |
Intendis, Inc. (Foley & Lardner LLP) - Citizen Petition FDA-2011-P-0227 Intendis, Inc. filed this citizen petition under sections 505(b), 505(j), and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA issue a timely response to Intendis' August 2010 comments on the May 2010 Draft Guidance on Azelaic Acid, stay the review and approval of any pendi | 505(q) Stay Request | 2011-04-11 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4604
per gm
Lowest NADAC/Unit
$0.4604
per gm
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00781717250AZELAIC ACID 15% GEL | $0.4604 | GM | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.