ISOTRETINOIN | A075945 | MYLAN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Sun Pharmaceutical Industries, Inc. - Citizen Petition FDA-2010-P-0171 · 8 docket documents Sun Pharmaceutical Industries, Inc., as the US Agent for Sun Pharma Global FZE, filed this citizen petition on March 22, 2010, requesting that the FDA determine the discontinued formulation of ACCUTANE (Isotretinoin capsules) in 10 mg, 20 mg, and 40 mg strengths was not withdrawn for safety or effic | Other | 2010-03-29 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.17
per ea
Lowest NADAC/Unit
$1.61
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00378661493AMNESTEEM 40 MG CAPSULE | $2.17 | EA | Generic | — | 2026-06-17 |
| 00378661393AMNESTEEM 30 MG CAPSULE | $2.10 | EA | Generic | — | 2026-06-17 |
| 00378661293AMNESTEEM 20 MG CAPSULE | $1.90 | EA | Generic | — | 2026-06-17 |
| 00378661193AMNESTEEM 10 MG CAPSULE | $1.61 | 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.