ATROPINE SULFATE | N206289 | RISING PHARMA HOLDINGS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 4 Draft Guidance on Atropine Sulfate re Suitability Petition from ... FDA-2023-P-4550 Pharmobedient Consulting LLC filed a petition regarding atropine sulfate seeking FDA guidance on the suitability of the drug substance for use in pharmaceutical formulations. The petition requests clarification on regulatory pathways and acceptance criteria for atropine sulfate submissions under app | Suitability | 2023-10-17 | Open | Pharmobedient Consulting LLC |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4550 Pharmobedient Consulting, LLC submitted this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Atropine Sulfate Ophthalmic Ointment, 1% suitable for submission in an ANDA, changing the dosage form from the reference listed dru | Suitability | 2023-10-17 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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