ISOTRETINOIN | N211913 | SUN PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Data Based Medicine Americas Ltd. FDA-2018-P-4088 · 8 docket documents Data Based Medicine Americas Ltd., represented by David Healy and colleagues, filed this citizen petition on October 26, 2018, requesting that the FDA immediately revise all isotretinoin product labels (both branded and generic formulations) to add warnings, precautions, highlights of prescribing in | Other | 2018-10-29 | Open | Data Based Medicine Americas Ltd. |
Citizen Petition from Morgan Lewis & Bockius LLP FDA-2014-P-1282 · 8 docket documents Morgan Lewis & Bockius LLP filed this suitability petition on behalf of an unnamed client under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare three new strengths of Isotretinoin Capsules USP (15 mg, 25 mg, and 35 mg) suitable for submission and FDA | Other | 2014-09-03 | Open | Morgan Lewis & Bockius LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$42.07
per ea
Lowest NADAC/Unit
$38.41
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 10631000731ABSORICA LD 32 MG CAPSULE | $42.07 | EA | Brand | — | 2026-06-17 |
| 10631000531ABSORICA LD 24 MG CAPSULE | $41.89 | EA | Brand | — | 2026-06-17 |
| 10631000331ABSORICA LD 16 MG CAPSULE | $38.41 | EA | Brand | — | 2025-12-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.