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20,170 catalysts · 4,728 grant · 3,122 device 510k · 3,086 8k filing · 2,796 approval · 2,000 device pma · 2,000 device recall
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20,170 catalysts · 4,728 grant · 3,122 device 510k · 3,086 8k filing · 2,796 approval · 2,000 device pma · 2,000 device recall
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Special
Product code: ETD. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OOE. Advisory committee: Ophthalmic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Sponsor: VERTICAL PHARMS. Form: GEL. Route: TRANSDERMAL
Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION
Product code: FMG. Advisory committee: General Hospital. Type: Traditional
Product code: EBI. Advisory committee: Dental. Type: Traditional
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Product code: KGC. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LYY. Advisory committee: General Hospital. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: BTR. Advisory committee: Anesthesiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: INVAGEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS
Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318 — Reason: CGMP Deviations — Status: Ongoing
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11 — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30 — Reason: cGMP deviations — Status: Terminated
DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15 — Reason: cGMP deviations — Status: Terminated
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10 — Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. — Status: Ongoing
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41. — Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922 — Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. — Status: Ongoing
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY — Reason: CGMP Deviations — Status: Terminated
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48. — Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units — Status: Ongoing
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41. — Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units — Status: Ongoing
Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15 — Reason: cGMP deviations — Status: Terminated
Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02 — Reason: cGMP deviations — Status: Terminated
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15 — Reason: cGMP deviations — Status: Terminated