ATROPINE SULFATE | N209260 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Biotech Research Group FDA-2023-P-5409 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 | Open | Biotech Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.