DIAZEPAM | A210363 | REGCON HOLDINGS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Citizen Petition from Lachman Consultant Services, Inc FDA-2023-P-4300 Lachman Consultant Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Diazepam Injection USP, 20 mg/4 mL (5 mg/mL) single dose prefilled syringe suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act, with the proposed product | Suitability | 2023-10-04 | Open | Lachman Consultant Services |
Suitability Petition from Lachman Consulting Services Inc FDA-2022-P-0118 Lachman Consulting Services Inc. filed a petition under section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Diazepam Injection USP, 20 mg/4 mL (5 mg/mL) single dose prefilled syringe suitable for submission as an abbreviated new drug application (ANDA), w | Suitability | 2022-02-03 | Open | Lachman Consulting Services Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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