SERTRALINE HYDROCHLORIDE | N019839 | VIATRIS SPECIALTY LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-3576 · 7 docket documents Lachman Consulting Services, Inc., on behalf of a client, filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Sertraline Hydrochloride Tablets, 12.5 mg suitable for submission as an Abbreviated New Drug Applicati | Suitability | 2025-09-05 | Open | Lachman Consulting Services, Inc. |
Suitability Petition from Premier Research Consulting, LLC FDA-2025-P-2590 · 7 docket documents Premier Research Consulting, LLC filed this ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA confirmation that Sertraline Hydrochloride Tablets at 75 mg strength is suitable for submission as a supplemental ANDA, with the 75 mg dos | Suitability | 2025-07-23 | Open | Premier Research Consulting, LLC |
Suitability Petition from Lachman Consulting Services, Inc. FDA-2024-P-3567 · 7 docket documents Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Sertraline Capsules in 25 mg, 50 mg, and 100 mg strengths suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act, citing Sertraline Capsules 150 mg and 200 m | Suitability | 2024-07-30 | Denied | Lachman Consulting Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$14.95
per ea
Lowest NADAC/Unit
$14.88
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 58151057688ZOLOFT 100 MG TABLET | $14.95 | EA | Brand | $0.0507 | 2026-06-17 |
| 58151057693ZOLOFT 100 MG TABLET | $14.95 | EA | Brand | $0.0507 | 2026-06-17 |
| 58151057588ZOLOFT 50 MG TABLET | $14.88 | EA | Brand | $0.0343 | 2026-06-17 |
| 58151057593ZOLOFT 50 MG TABLET | $14.88 | EA | Brand | $0.0343 | 2026-06-17 |
| 00049490030ZOLOFT 50 MG TABLET | $14.88 | EA | Brand | $0.0343 | 2026-06-17 |
| 58151057493ZOLOFT 25 MG TABLET | $14.88 | EA | Brand | $0.0286 | 2026-01-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.