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21,502 catalysts · 4,728 grant · 3,831 device 510k · 3,311 8k filing · 3,041 approval · 2,000 device pma · 2,000 device recall
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21,502 catalysts · 4,728 grant · 3,831 device 510k · 3,311 8k filing · 3,041 approval · 2,000 device pma · 2,000 device recall
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency. — Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. — Status: Ongoing
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box). — Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20. — Reason: Super-Potent Drug: Out of specification potency results were obtained. — Status: Ongoing
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04 — Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. — Status: Ongoing
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30 — Reason: Failed Dissolution Specifications — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. — Status: Ongoing
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DSP. Advisory committee: Cardiovascular. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: JXE. Advisory committee: Neurology. Type: Traditional
Product code: QPF. Advisory committee: Neurology. Type: Special
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: QJF. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: TABLET. Route: ORAL
Product code: KPI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QOG. Advisory committee: General Hospital. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Special
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QPL. Advisory committee: Neurology. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: OEB. Advisory committee: Radiology. Type: Traditional
Product code: PIW. Advisory committee: Neurology. Type: Traditional
Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: BRAEBURN. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: JBQ. Advisory committee: Hematology. Type: Traditional
Product code: BWK. Advisory committee: Unknown. Type: Traditional
Product code: LGD. Advisory committee: Microbiology. Type: Traditional
Product code: KNT. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special