Requests that the FDA determine whether the proposed Heparin Sodium Injection, USP 25,000 USP Units/5mL (5,000 USP Units/mL) [Multiple Dose Vial] (with Preservative – Benzyl Alcohol) is suitable for submission as a supplemental Abbreviated New Drug Application (sANDA) | Federal Regulations · Congress.wiki

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FDA

FDA-2025-P-5739

Requests that the FDA determine whether the proposed Heparin Sodium Injection, USP 25,000 USP Units/5mL (5,000 USP Units/mL) [Multiple Dose Vial] (with Preservative – Benzyl Alcohol) is suitable for submission as a supplemental Abbreviated New Drug Application (sANDA)

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 31, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Shenzhen Techdow Pharmaceutical Co., Ltd.	Apr 8, 2026	--

Keywords

CDER

Suitability Petition

Shenzhen Techdow Pharmaceutical Co., Ltd.

Requests that the FDA determine whether the

proposed Heparin Sodium Injection, USP 25,000

USP Units/5mL (5,000 USP Units/mL)

[Multiple Dose Vial] (with Preservative –

Benzyl Alcohol) is suitable for submission as a

Data from Regulations.gov