ATROPINE SULFATE | N020056 | UNITED STATES ARMY OFFICE SURGEON GENERAL
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 4 Draft Guidance on Atropine Sulfate re Suitability Petition from ... FDA-2023-P-4550 · 8 docket documents 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 | Denied | Pharmobedient Consulting LLC |
Citizens Petition from Lachman Consultant Services, Inc. FDA-2005-P-0134 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP at a strength of 5 mg/0.05 mg per 5 mL suitable for sub | Other | 2008-12-24 | Denied | Lachman Consultant Services, Inc. |
Citizens Petition from Lachman Consultant Services, Inc. FDA-2005-P-0381 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on April 25, 2005, requesting that the FDA declare Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP 5 mg/0.05 mg suitable for submission as an ANDA based on the reference listed drug Lomotil Tablets 2.5 mg/0.025 mg. The petition seeks | Other | 2008-12-24 | Denied | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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