PAROXETINE HYDROCHLORIDE | N020031 | APOTEX INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from George W. Murgatroyd III FDA-2025-P-3263 · 41 docket documents George W. Murgatroyd III filed this citizen petition under 21 CFR 10.30 requesting that the FDA publicly disavow the 2001 Keller article in the Journal of the American Academy of Child & Adolescent Psychiatry regarding paroxetine (Paxil) for adolescent depression, issue a Drug Safety Communication w | Other | 2025-08-20 | Denied | George W. Murgatroyd III |
Suitability Petition from Lachman Consulting Services, Inc. FDA-2023-P-4289 · 7 docket documents Lachman Consulting Services, Inc. submitted this suitability petition on behalf of a client requesting that the FDA declare Paroxetine Orally Disintegrating Tablets in 10 mg, 20 mg, 30 mg, and 40 mg strengths suitable for submission in an ANDA under Section 505(j)(2)(C) of the FDC Act, with the refe | Suitability | 2023-10-03 | Denied | Lachman Consulting Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$11.69
per ea
Lowest NADAC/Unit
$10.66
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 60505452003PAXIL 40 MG TABLET | $11.69 | EA | Brand | $0.1037 | 2026-06-17 |
| 60505451903PAXIL 30 MG TABLET | $10.81 | EA | Brand | $0.0947 | 2026-06-17 |
| 60505451803PAXIL 20 MG TABLET | $10.66 | EA | Brand | $0.0674 | 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.