# Aspen Global Inc. c/o Lachman Consultant Services, Inc., et al.; Withdrawal of Approval of 46 New Drug Applications
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 46 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
**DATES:**
Approval is withdrawn as of April 8, 2026.
**FOR FURTHER INFORMATION CONTACT:**
Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137, *[email protected].*
**SUPPLEMENTARY INFORMATION:**
The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
| Application No. | Drug | Applicant |
| --- | --- | --- |
| NDA 000552 | Liquaemin Sodium (heparin sodium) injectable, 1,000 units/milliliter (mL), 5,000 units/mL, 10,000 units/mL, 20,000 units/mL, and 40,000 units/mL | Aspen Global Inc. c/o Lachman Consultant Services, Inc., 1600 Stewart Ave., Westbury, NY 11590. |
| | Liquaemin Sodium Preservative Free (heparin sodium) injectable, 1,000 units/mL, 5,000 units/mL, and 10,000 units/mL | |
| | Liquaemin Lock Flush (heparin sodium) injectable, 100 units/mL | |
| | Heparin Sodium (heparin sodium) injectable, 1,000 units/mL, 5,000 units/mL, and 10,000 units/mL | |
| NDA 008370 | Bentyl (dicyclomine hydrochloride (HCl)) injectable, 10 milligrams (mg)/mL | AbbVie Inc., 1 N Waukegan Rd., North Chicago, IL 60064. |
| | Bentyl Preservative Free (dicyclomine HCl) injectable, 10 mg/mL | |
| NDA 008943 | Diamox (acetazolamide) tablets, 125 mg and 250 mg | Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Parkway, West Chester, PA 19380. |
| NDA 011600 | Triamcinolone Acetonide (triamcinolone acetonide) ointment, 0.025%, and 0.1% | Extrovis AG c/o Masuu Global Solutions LLC, 2255 Glades Rd., Suite 324A, Boca Raton, FL 33431. |
| NDA 012250 | Carbocaine (mepivacaine HCl) injectable, 1%, 1.5%, and 2% | Hospira, Inc., a Pfizer company, 275 North Field Dr., Lake Forest, IL 60045. |
| NDA 012623 | Flagyl (metronidazole) tablets, 250 mg and 500 mg | Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001. |
| NDA 017498 | Micronase (glyburide) tablets, 1.25 mg, 2.5 mg, and 5 mg | Do. |
| NDA 017630 | Sodium Iodide I-123 (sodium iodide I-123) capsules, 100 microcurie (μCi), 200 μCi, and solution, 2 millicurie (mCi)/mL | GE HealthCare, 3350 North Ridge Ave., Arlington Heights, IL 60004. |
| NDA 017741 | Florone (diflorasone diacetate) cream, 0.05% | Pfizer Inc. |
| NDA 017802 | Lo/Ovral-28 (ethinyl estradiol; norgestrel) tablets, 0.03 mg; 0.3 mg | Wyeth Pharmaceuticals LLC c/o Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001. |
| NDA 017948 | Norminest Fe (tablets, ethinyl estradiol; norethindrone, 0.035 mg; 0.5 mg, and tablets, ferrous fumarate, 75 mg) | Pfizer Inc. |
| NDA 018647 | Corzide (bendroflumethiazide; nadolol) tablets, 5 mg; 40 mg and 5 mg; 80 mg | King Pharmaceuticals LLC, c/o Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001. |
| NDA 018799 | Protopam (pralidoxime chloride) injectable, 300 mg/mL | Baxter Healthcare Corp., 25212 W Illinois Route 120, Round Lake, IL 60073. |
| NDA 018926 | Norquest Fe (tablets, ethinyl estradiol; norethindrone, 0.035 mg; 1 mg, and tablets, ferrous fumarate, 75 mg) | Pfizer Inc. |
| NDA 018947 | Sodium Lactate in Plastic Container (sodium lactate), injectable, 50 milliequivalents (mEq)/mL | Hospira, Inc. |
| NDA 019190 | Triphasil-28 (ethinyl estradiol; levonorgestrel) tablets, 0.03 mg; 0.05 mg, tablets, 0.04 mg; 0.075 mg, and tablets, 0.03 mg; 0.125 mg | Wyeth Pharmaceuticals c/o Pfizer Inc. |
| NDA 019192 | Triphasil-21 (ethinyl estradiol; levonorgestrel) tablets, 0.03 mg; 0.05 mg, tablets, 0.04 mg; 0.075 mg, and tablets, 0.03 mg; 0.125 mg | Do. |
| NDA 019885 | Accupril (quinapril HCl) tablets, equivalent to (EQ) 5 mg base, EQ 10 mg base, EQ 20 mg base, and EQ 40 mg base | Pfizer Inc. |
| NDA 019941 | Emla (lidocaine; prilocaine) cream, 2.5%; 2.5% | Teva Branded Pharmaceutical Products R&D Inc. |
| NDA 019966 | Temovate (clobetasol propionate) solution, 0.05% | Fougera Pharmaceuticals Inc., c/o Sandoz (a subsidiary of Novartis), 100 College Rd., West, Princeton, NJ 08540. |
| NDA 020051 | Glynase (glyburide) tablets, 1.5 mg, 3 mg, 4.5 mg, and 6 mg | Pfizer Inc. |
| NDA 020125 | Accuretic (hydrochlorothiazide; quinapril HCl) tablets, 12.5 mg; EQ 10 mg base, 12.5 mg; EQ 20 mg base, and 25 mg; EQ 20 mg base | Do. |
| NDA 020430 | Orgaran (danaparaoid sodium) injectable, 750 units/0.6 mL | Aspen Global Inc. c/o Lachman Consultant Services, Inc. |
| NDA 020682 | Glyset (miglitol) tablets, 25 mg, 50 mg, and 100 mg | Pfizer Inc. |
| NDA 020859 | Sonata (zaleplon) capsules, 5 mg and 10 mg | Do. |
| NDA 020862 | Hectorol (doxercalciferol) capsules, 0.5 microgram (mcg), 1 mcg, and 2.5 mcg | Genzyme Corp., a Sanofi company, 450 Water St., Cambridge, MA 02141. |
| NDA 020868 | Flagyl ER (metronidazole) extended-release tablet, 750 mg | Pfizer Inc. |
| NDA 021350 | Triglide (fenofibrate) tablets, 50 mg and 160 mg | Jagotec AG c/o. ICON, 731 Arbor Way, Suite 100, Blue Bell, PA 19422. |
| NDA 021520 | Symbyax (fluoxetine HCl; olanzapine) capsules, EQ 25 mg base; EQ 3 mg base, EQ 25 mg base; EQ 6 mg base, EQ 25 mg base; EQ 12 mg base, EQ 50 mg base; EQ 6 mg base, and EQ 50 mg base; EQ 12 mg base | Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285. |
| NDA 021688 | Sensipar (cinacalcet HCl) tablets, EQ 30 mg base, EQ 60 mg base, and EQ 90 mg base | Amgen, Inc., 1 Amgen Center Dr., Thousand Oaks, CA 91320-1799. |
| NDA 022200 | Bydureon (exenatide synthetic) extended-release injection for suspension, 2 mg/vial | AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803. |
| | Bydureon Pen (exenatide synthetic) extended-release injection for suspension, 2 mg | |
| NDA 050168 | Cortisporin (bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin B sulfate) ointment, 400 units/gram (g); 1%; EQ 3.5 mg base/g; 5,000 units/g | Monarch Pharmaceuticals, LLC c/o Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001. |
| NDA 050218 | Cortisporin (hydrocortisone acetate; neomycin sulfate; polymyxin B sulfate) cream, 0.5%; EQ 3.5 mg base/g; 10,000 units/g | Do. |
| NDA 050420 | Rifadin (rifampin) capsules, 150 mg and 300 mg | Sanofi-Aventis U.S. LLC, a Sanofi company, 55 Corporate Dr., Bridgewater, NJ 08807. |
| NDA 050479 | Cortisporin (hydrocortisone; neomycin sulfate; polymyxin B sulfate) otic solution/drops, 1%; EQ 3.5 mg base/mL; 10,000 units/mL | Monarch Pharmaceuticals, LLC c/o Pfizer Inc. |
| NDA 050533 | Vibra-Tabs (doxycycline hyclate) tablet, EQ 100 mg base | Pfizer Inc. |
| NDA 050661 | Idamycin (idarubicin HCL) powder, 5 mg/vial, 10 mg/vial, and 20 mg/vial | Pfizer Inc. |
| NDA 050705 | Rifater (isoniazid; pyrazinamide; rifamin) tablets, 50 mg; 300 mg; 120 mg | Sanofi-Aventis U.S. LLC, a Sanofi company, 100 Morris St., Morristown, NJ 07960. |
| NDA 201657 | Paricalcitol (paricalcitol) solution, 0.002 mg/mL (0.002 mg/mL), 0.005 mg/mL (0.005 mg/mL), and 0.01 mg/2 mL (0.005 mg/mL) | Hospira, Inc. |
| NDA 204016 | Zoledronic Acid (zoledronic acid) solution, EQ 4 mg base/100 mL (EQ 0.04 mg base/mL) | Do. |
| NDA 204300 | Vazculep (phenylephrine HCL) solution, 10 mg/mL (10 mg/mL), 50 mg/5 mL (10 mg/mL), and 100 mg/10 mL (10 mg/mL) | Exela Pharma Sciences, LLC, P.O. Box 818, 1245 Blowing Rock Blvd., Lenoir, NC 28645. |
| NDA 207202 | Abilify MyCite Kit (aripiprazole) tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg | Otsuka Pharmaceutical Co., Ltd., c/o Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Blvd., Rockville, MD 208500. |
| NDA 208614 | Doxercalciferol (doxercalciferol) injectable, 4 mcg/2 mL (2 mcg/mL) and 10 mcg/5 mL (2 mcg/mL) | Hospira, Inc. |
| NDA 209210 | Bydureon BCise (exenatide synthetic) extended-release injection suspension, 2 mg/0.85 mL | AstraZeneca Pharmaceuticals LP. |
| NDA 209269 | Minolira (minocycline HCl) extended-release tablets, EQ 105 mg base and EQ 135 mg base | EPI Health, LLC, 174 Meeting St., Suite 200, Charleston, SC 29401. |
| NDA 209607 | Azedra (iobenguane I-131) solution, 15 mCi/mL | Progenics Pharmaceuticals, Inc., a Lantheus company, 201 Burlington Rd., South Building, Bedford, MA 01730. |
Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of April 8, 2026. Approval of each entire application is withdrawn, including any strengths and dosage forms included in the application but inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved NDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in table 1 that are in inventory on April 8, 2026 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.