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Federal Register · Regulatory notice

Determination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

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Became public
Jun 8, 2026
Event / period date
Not stated
Collected
Nov 7, 2026, 7:16 PM EST

Why this is connected

The source explicitly mentions PFIZER INC. A mention alone does not establish a financial benefit.

Source evidence

Read the source excerpt or record
um. 2.5 mg Base/mL; Injection. METHOTREXTATE EQ 20 mg Base/2 LPF AND mL (EQ 10 mg METHOTREXATE Base/mL); EQ 20 PRESERVATIVE mg Base/Vial; FREE. EQ 25 mg Base/ mL; EQ 25 mg Base/mL; EQ 2.5 grams (g) Base/ 100 mL (EQ 25 mg Base/mL); EQ 50 mg Base/ Vial; EQ 100 mg Base/Vial; EQ 1g Base/Vial. NDA 012250.......... CARBOCAINE....... Mepivacaine 1%; 1.5%; 2%.... Injectable; Hospira, Inc. Hydrochloride. Injection. NDA 016909.......... LIDEX............ Fluocinonide..... 0.05%........... Ointment; Alvogen, Inc. Topical. NDA 017010.......... DESONIDE......... Desonide......... 0.05%........... Cream; Topical.. Padagis LLC. NDA 017735.......... MODICON 28....... Ethinyl 0.035 mg; 0.5 mg Tablet; Oral-28. Janssen Estradiol; Pharmaceuticals Norethindrone. , Inc. NDA 018337.......... ACETAMINOPHEN.... Acetaminophen.... 650 mg.......... Suppository; Taro Rectal. Pharmaceutical Industries Ltd. NDA 019260.......... PSORCON.......... Diflorasone 0.05%........... Ointment; Pfizer Inc. Diacetate. Topical. NDA 019487 P001..... IMODIUM A-D...... Loperamide 1 mg/5 mL....... Solution; Oral.. Kenvue Brands Hydrochloride. LLC. NDA 020021.......... SUDAFED 24 HOUR.. Pseudoephedrine 240 mg.......... Tablet, Extended Kenvue Brands Hydrochloride. Release; Oral. LLC. NDA 020449.......... TAXOTERE......... Docetaxel........ 20 mg/mL (20 mg/ Injectable; Sanofi-Aventis mL); 80 mg/4 mL Injection. U.S. LLC. (20 mg

Congressional trading in PFE

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Original documents control. Public records can be amended, and company connections may require interpretation. Nothing here is investment advice.