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21,839 catalysts · 4,728 grant · 4,071 device 510k · 3,288 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
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21,839 catalysts · 4,728 grant · 4,071 device 510k · 3,288 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
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
Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional
Product code: QQC. Advisory committee: Neurology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Special
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: QZX. Advisory committee: Microbiology. Type: Traditional
Product code: SEA. Advisory committee: Microbiology. Type: Direct
Product code: GZL. Advisory committee: Neurology. Type: Special
Product code: GYC. Advisory committee: Neurology. Type: Traditional
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL
Sponsor: ALVOGEN. Form: TABLET. Route: ORAL
Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: MUM. Advisory committee: General, Plastic Surgery. Type: Special
Product code: EBI. Advisory committee: Dental. Type: Traditional
Product code: KTI. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MOF. Advisory committee: Cardiovascular. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EGJ. Advisory committee: Physical Medicine. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Special
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Special
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: NANJING KING FRIEND. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. — Reason: Presence of Foreign Tablets/Capsules. — Status: Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 — Reason: Lack of Assurance of Sterility — Status: Ongoing
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109. — Reason: Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol — Status: Ongoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4 — Reason: Lack of Assurance of Sterility — Status: Ongoing