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21,460 catalysts · 4,728 grant · 3,940 device 510k · 3,100 approval · 3,080 8k filing · 2,000 device pma · 2,000 device recall
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21,460 catalysts · 4,728 grant · 3,940 device 510k · 3,100 approval · 3,080 8k filing · 2,000 device pma · 2,000 device recall
Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: SPROUT PHARMS. Form: TABLET. Route: ORAL
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: FBN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QHE. Advisory committee: Orthopedic. Type: Special
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Sponsor: AIPING PHARM INC. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL
Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: SHANDONG LUYE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL
Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL
Sponsor: ASTELLAS. Form: TABLET. Route: ORAL
Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN PHARMS. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11 — Reason: Failed Dissolution Specifications: — Status: Terminated
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01. — Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. — Status: Ongoing
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11 — Reason: Presence of Foreign Tablets/Capsules — Status: Ongoing
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2. — Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. — Status: Ongoing
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02. — Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. — Status: Ongoing
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