LEVOTHYROXINE SODIUM | N021402 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from VRT Pharma Consulting, LLC FDA-2023-P-5654 · 14 docket documents VRT Pharma Consulting LLC, on behalf of Neuheit Pharma Technologies Private Ltd, filed an amendment to a suitability petition seeking FDA permission to submit an ANDA for levothyroxine sodium sublingual tablets in 12 strengths ranging from 25 mcg to 300 mcg as a change in route of administration fro | Suitability | 2024-02-02 | Denied | — |
Suitability Petition from Neuheit Pharma Technologies Pvt Ltd. FDA-2023-P-1988 · 10 docket documents Neuheit Pharma Technologies Pvt Ltd filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Levothyroxine sodium sublingual tablets in strengths of 25 mcg through 300 mcg are suitable for submission in an Abbreviat | Suitability | 2023-05-17 | Withdrawn | Neuheit Pharma Technologies Pvt Ltd. |
Knoll Pharmaceutical Company - Citizen Petition (CP2) FDA-1997-N-0041 · 30 docket documents Knoll Pharmaceutical Company submitted this citizen petition on December 15, 1997, requesting that the FDA Commissioner determine that Synthroid, an orally administered levothyroxine sodium product, is generally recognized as safe and effective under section 201(p) of the Food, Drug, and Cosmetic Ac | Other | 2009-01-24 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.66
per ea
Lowest NADAC/Unit
$1.66
per ea
Brand NDCs
30
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00074372790SYNTHROID 137 MCG TABLET | $1.66 | EA | Brand | $0.0630 | 2026-06-17 |
| 00074372719SYNTHROID 137 MCG TABLET | $1.66 | EA | Brand | $0.0630 | 2026-06-17 |
| 00074662490SYNTHROID 100 MCG TABLET | $1.66 | EA | Brand | $0.0509 | 2026-06-17 |
| 00074662419SYNTHROID 100 MCG TABLET | $1.66 | EA | Brand | $0.0509 | 2026-06-17 |
| 00074662411SYNTHROID 100 MCG TABLET | $1.66 | EA | Brand | $0.0509 | 2026-06-17 |
| 00074706911SYNTHROID 150 MCG TABLET | $1.66 | EA | Brand | $0.0635 | 2026-06-17 |
Showing 6 of 30 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.