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20,113 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma
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20,113 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma
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Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: TRIS PHARMA INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL
Sponsor: ABON PHARMS LLC. Form: TABLET. Route: ORAL
Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR
Sponsor: EUGIA PHARMA. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL
Sponsor: COMMAVE THERAP. Form: CAPSULE. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: CHARTWELL RX. Form: FOR SUSPENSION. Route: ORAL
Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION
Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION
Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR
Sponsor: HERITAGE PHARMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: TAKEDA PHARMS USA. Form: TABLET, CHEWABLE. Route: ORAL
Sponsor: RHODES PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: TRIS PHARMA INC. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL
Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS
Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL
Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL
Sponsor: NEOS THERAPS INC. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: LABORATOIRE HRA. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: CAPSULE. Route: ORAL
Sponsor: MEDRX USA. Form: SYSTEM. Route: TOPICAL
Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION
Sponsor: NE RX PHARMA. Form: TABLET. Route: ORAL
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. — Reason: Failed Impurity/Degradation Specifications — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11) — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11) — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60. — Reason: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. — Status: Ongoing
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60. — Reason: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11) — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03 — Reason: Superpotent drug — Status: Ongoing
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1 — Reason: Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19. — Reason: Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). — Status: Ongoing
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. — Reason: Failed Impurity/Degradation Specifications — Status: Ongoing
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10. — Reason: cGMP deviations: Temperature excursion during transportation. — Status: Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203. — Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL
Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL