GE HealthCare, et al.; Withdrawal of Approval of 18 New Drug Applications

NDA 011386 Hypaque (diatrizoate sodium) for solution, 100%. Hypaque (diatrizoate sodium) solution, 40% GE HealthCare, 251 Locke Dr., Marlborough, MA 01752. NDA 017944 MPI DMSA Kidney Reagent (technetium Tc 99m succimer kit), injectable Do. NDA 018045 Emcyt (estramustine phosphate sodium) capsule, equivalent to (EQ) 140 milligrams (mg) phosphate Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001. NDA 018141 Technetium Tc 99m MPI MDP (technetium Tc-99m medronate kit), injectable GE HealthCare. NDA 019697 Ortho Tri-Cyclen (ethinyl estradiol and norgestimate, 0.035 mg/0.180 mg; ethinyl estradiol and norgestimate, 0.035 mg/0.215 mg; ethinyl estradiol and norgestimate, 0.035 mg/0.250 mg) tablets Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560. NDA 019862 Indiclor (indium In-111 chloride) injectable, 2 millicurie/0.2 milliliters (mL) GE HealthCare. NDA 019937 Adenocard (adenosine) injectable, 3 mg/mL Astellas Pharma US, Inc., 1 Astellas Way, Northbrook, IL 60062. NDA 020357 Glucophage (metformin hydrochloride (HCl)) tablets, 500 mg, 625 mg, 750 mg, 850 mg, and 1 g EMD Serono, Inc., 200 Pier 4 Blvd., Suite 300, Boston, MA 02210. NDA 020489 Androderm (testosterone) extended-release transdermal film, 1 mg/24 hours (h), 2.5 mg/24 h, 4 mg/24 h, and 5 mg/24 h AbbVie Inc., 1 N Waukegan Rd., North Chicago, IL 60064. NDA 020613 Alphagan (brimonidine tartrate) solution/drops, 0.2% Allergan, Inc., 2525 Dupont Dr., Irvine, CA 92612. NDA 021145 Vaniqa (eflornithine HCl) cream, 13.9% AbbVie Inc. NDA 021202 Glucophage XR (metformin HCl), extended-release tablets, 500 mg and 750 mg EMD Serono, Inc. NDA 021565 Elestat (epinastine HCl) ophthalmic solution/drops, 0.05% Allergan, Inc. NDA 021756 Macugen (pegaptanib sodium) intravitreal injectable, EQ 0.3 mg acid/0.09 mL Bausch & Lomb Inc., 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. NDA 201152 Viramune XR (nevirapine) extended-release tablets, 100 mg and 400 mg Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, P.O. Box 368, Ridgefield, CT 06877. NDA 203585 Synribo (omacetaxine mepesuccinate) powder for subcutaneous injection, 3.5 mg/vial Teva Pharmaceuticals GmbH, C/O Teva Branded Pharmaceuticals Products R&D, 145 Brandywine Parkway, West Chester, PA 19380. NDA 208424 GoNitro (nitroglycerin) sublingual powder, 0.4 mg/packet G. Pohl-Boskamp GmbH & Co. KG, C/O Allegis Pharmaceuticals, LLC, 276 Nissan Parkway F100, Canton, MS 39046. NDA 212121 Potassium Phosphates (potassium phosphate, dibasic and potassium phosphate, monobasic) solution, 4.5 g/15 mL (300 mg/mL), and 2.65 g/15 mL (175 mg/mL) CMP Development LLC, 8026 East Marlboro Rd., Farmville, NC 27828.