SULINDAC | A071795 | WATSON LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 -Orange Book -CLINORIL (SULINDAC)-1 re: Suitability Petition fro... FDA-2023-P-4358 · 9 docket documents Pharmobedient Consulting, LLC filed a suitability petition regarding Clinoril (sulindac) seeking to establish the suitability of the drug for inclusion in the Orange Book, which would allow for abbreviated new drug applications (ANDAs) to reference the approved brand-name product. | Suitability | 2023-10-06 | Granted | Pharmobedient Consulting, LLC |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0647 · 6 docket documents Lachman Consultant Services, Inc. filed this petition under Section 505(j)(2)(C) requesting that the FDA declare Sulindac Capsules, 200 mg suitable for submission in an ANDA, with the reference listed drug being Clinoril Sulindac Tablets, 200 mg. The petitioner seeks approval to change the dosage fo | Other | 2008-12-17 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.2362
per ea
Lowest NADAC/Unit
$0.2362
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00591566001SULINDAC 200 MG TABLET | $0.2362 | EA | Generic | — | 2026-06-17 |
| 00591566005SULINDAC 200 MG TABLET | $0.2362 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.