SELENIOUS ACID | A218661 | CIPLA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - SELENIOUS ACID- selenious acid injection, solution RE Suitabil... FDA-2023-P-4465 Pharmobedient Consulting, LLC filed a suitability petition regarding selenious acid injection, solution, requesting FDA determination on the suitability of the product for approval through the abbreviated new drug application (ANDA) pathway or other appropriate regulatory mechanisms. | Suitability | 2023-10-11 | Open | Pharmobedient Consulting |
Attachment 4 - Draft Guidance on Selenious Acid RE Suitability Petition from ... FDA-2023-P-4465 Pharmobedient Consulting, LLC filed a petition requesting FDA guidance on the regulatory suitability of selenious acid as a pharmaceutical ingredient. The petition seeks clarification through draft guidance documentation to establish the regulatory pathway and acceptability standards for selenious a | Suitability | 2023-10-11 | Open | Pharmobedient Consulting |
Attachment 2 - SELENIOUS ACID- selenious acid injection, solution RE Suitabil... FDA-2023-P-4465 Pharmobedient Consulting, LLC filed a suitability petition regarding selenious acid injection, solution, requesting FDA evaluation of the drug's suitability for approval or regulatory status determination. | Suitability | 2023-10-11 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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