calendar
577 catalysts · 522 grant · 20 approval · 15 device pma · 13 device 510k · 7 recall
next 91 dayslessmore
MonWedFri
577 catalysts · 522 grant · 20 approval · 15 device pma · 13 device 510k · 7 recall
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL
Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: AKEBIA. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: TABLET. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44 — Reason: Subpotent Drug — Status: Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217. — Reason: Failed tablet specifications. — Status: Ongoing
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: HLZ. Advisory committee: Ophthalmic. Type: Traditional
Product code: SHN. Advisory committee: Radiology. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Special
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Supplement type: Real-Time Process. Product code: NQO. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: OK30
Supplement type: Special (Immediate Track). Product code: PYX. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30