LEVOTHYROXINE SODIUM | N021402 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Neuheit Pharma Technologies Pvt Ltd. FDA-2023-P-1988 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 | Open | Neuheit Pharma Technologies Pvt Ltd. |
Attachment 2 - Labeling for SYNTHROID (Levothyroxine sodium) tablets RE Suita... FDA-2023-P-1988 Neuheit Pharma Technologies Pvt Ltd filed a suitability petition regarding labeling for SYNTHROID (levothyroxine sodium) tablets, seeking FDA review and approval of proposed labeling changes for this levothyroxine sodium product. | Suitability | 2023-05-17 | Open | Neuheit Pharma Technologies Pvt Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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