HEPARIN SODIUM | N017651 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Shenzhen Techdow Pharmaceutical Co., Ltd. FDA-2025-P-5739 Shenzhen Techdow Pharmaceutical Co., Ltd. filed this ANDA Suitability Petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act seeking FDA permission to submit a supplemental ANDA for Heparin Sodium Injection, USP 25,000 USP Units/5mL with benzyl alcohol preservative, a new st | Suitability | 2025-10-31 | Open | Shenzhen Techdow Pharmaceutical Co. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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