ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | A040357 | STRIDES PHARMA INTERNATIONAL AG
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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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