ATROPINE SULFATE | N209260 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Biotech Research Group FDA-2023-P-5409 · 8 docket documents Biotech Research Group filed this ANDA suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug & Cosmetic Act and 21 CFR 314.93, requesting FDA approval to permit submission of Abbreviated New Drug Applications for Atropine Sulfate Injection, USP at a higher strength of 4.0 m | Suitability | 2023-12-12 | Denied | Biotech Research Group |
Citizen Petition from Jerry Taylor Reed FDA-2018-P-2040 · 6 docket documents Jerry Taylor Reed filed this ANDA suitability petition pursuant to Section 505(j)(2)(C) requesting that the FDA declare Atropine Sulfate Injection, USP at 1.0 mg/mL and 0.4 mg/mL in 1 mL single dose vials suitable for submission in an ANDA, with the proposed products differing from the reference lis | Other | 2018-05-29 | Withdrawn | Jerry Taylor Reed |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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