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21,698 catalysts · 4,728 grant · 4,071 device 510k · 3,147 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
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21,698 catalysts · 4,728 grant · 4,071 device 510k · 3,147 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134 — Reason: Non-Sterility — Status: Ongoing
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 . — Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. — Status: Ongoing
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93 — Reason: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. — Status: Terminated
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1. — Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. — Status: Ongoing
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01. — Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. — Status: Ongoing
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93 — Reason: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. — Status: Terminated
Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02 — Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. — Status: Ongoing
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GWF. Advisory committee: Neurology. Type: Special
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JDW. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LHI. Advisory committee: General Hospital. Type: Traditional
Product code: OMB. Advisory committee: Neurology. Type: Traditional
Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ONB. Advisory committee: General Hospital. Type: Special
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: CAPSULE. Route: ORAL
Product code: LDF. Advisory committee: Cardiovascular. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: GXI. Advisory committee: Neurology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: HTN. Advisory committee: Orthopedic. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS
Product code: KDL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DFC. Advisory committee: Immunology. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: QPN. Advisory committee: Pathology. Type: Traditional
Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: NHN. Advisory committee: Physical Medicine. Type: Traditional
Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL