LEVOTHYROXINE SODIUM | N021116 | ALVOGEN INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 6 - Reference paper on factors affecting gastrointestinal absorpti... FDA-2023-P-1988 Neuheit Pharma Technologies Pvt Ltd filed a petition regarding levothyroxine sodium, submitting a reference paper by Skelin and colleagues examining factors affecting gastrointestinal absorption of this thyroid hormone replacement therapy to support arguments related to regulatory equivalence suitab | 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. |
Attachment 4 - Guidance for Generic Drug Development for bioequivalence studi... FDA-2023-P-1988 Neuheit Pharma Technologies Pvt Ltd filed a petition requesting FDA guidance on bioequivalence study design and suitability requirements for developing generic levothyroxine sodium tablets. The petition seeks clarification on the appropriate regulatory pathway and bioequivalence standards for this n | Suitability | 2023-05-17 | Open | Neuheit Pharma Technologies Pvt Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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