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数据说明

1. 本数据库涵盖了至目前为止所有经美国食品药品监督管理局(U.S. Food and Drug Administration)批准在美国上市的全部药品,并每天保持与FDA官网的同步更新。
2. 在官网基础上,新增多维度检索,包括:活性成分、商品名、公司、剂型、给药途径、注册审批号、化学类型、批准日期、审评分类、市场状态、是否参比药物、是否参比标准。
3. 通过药渡数据的一键检索,可以实现上述多维度检索美国上市的药品信息。
4. 检索结果包括FDA批准的药品审批注册信息及相关文件,包含历史审批数据如批准时间、修订内容、审批文档、批准函和说明书等。
5. 将FDA批准的药物与药渡数据中的药物做了人工关联,支持药物中英文名称和各种药物别名搜索,并且本数据库对首批时间在1995年后的上市新药进行了人工标定。

关闭

FDA批准 筛选 共39463条数据
更新日期:2019-05-20

  • 活性成分
  • 剂型
    • AEROSOL
    • AEROSOL, FOAM
    • AEROSOL, METERED
    • BAR, CHEWABLE
    • CAPSULE
    • CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET
    • CAPSULE, COATED PELLETS
    • CAPSULE, DELAYED REL PELLETS
    • CAPSULE, DELAYED REL PELLETS, TABLET
    • CAPSULE, DELAYED RELEASE
    • CAPSULE, EXTENDED RELEASE
    • CAPSULE, PELLET
    • CAPSULE, TABLET, CAPSULE, DELAYED RELEASE
    • CAPSULE; CAPSULE, DELAYED REL PELLETS; TABLET
    • CLOTH
    • CONCENTRATE
    • CREAM
    • CREAM, AUGMENTED
    • CREAM, SUPPOSITORY
    • CREAM, TABLET
    • DISC
    • DRESSING
    • ELIXIR
    • EMULSION
    • ENEMA
    • FIBER, EXTENDED RELEASE
    • FILM
    • FILM, EXTENDED RELEASE
    • FOAM
    • FOR SOLUTION
    • FOR SOLUTION, TABLET, DELAYED RELEASE
    • FOR SOLUTION, TABLET, FOR SOLUTION
    • FOR SUSPENSION
    • FOR SUSPENSION, DELAYED RELEASE
    • FOR SUSPENSION, EXTENDED RELEASE
    • FOR SUSPENSION, TABLET
    • GAS
    • GEL
    • GEL, AUGMENTED
    • GEL, METERED
    • GRANULE
    • GRANULE, DELAYED RELEASE
    • GRANULE, EFFERVESCENT
    • GUM, CHEWING
    • IMPLANT
    • INHALANT
    • INJECTABLE
    • INJECTABLE, LIPID COMPLEX
    • INJECTABLE, LIPOSOMAL
    • INJECTABLE, SUSPENSION
    • INJECTABLE, TABLET
    • INJECTION, EXTENDED RELEASE
    • INSERT
    • INSERT, EXTENDED RELEASE
    • INTRAUTERINE DEVICE
    • JELLY
    • KIT
    • LIQUID
    • LOTION
    • LOTION, AUGMENTED
    • LOTION/SHAMPOO
    • N/A
    • OIL
    • OIL/DROPS
    • OINTMENT
    • OINTMENT, AUGMENTED
    • PASTE
    • PASTILLE
    • PATCH
    • PELLET
    • PELLETS
    • POWDER
    • POWDER FOR ORAL SOLUTION
    • POWDER FOR ORAL SUSPENSION
    • POWDER, EXTENDED RELEASE
    • POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
    • POWDER, METERED
    • RING
    • SHAMPOO
    • SOAP
    • SOLUTION
    • SOLUTION FOR SLUSH
    • SOLUTION, ELIXIR
    • SOLUTION, EXTENDED RELEASE
    • SOLUTION, GEL FORMING/DROPS
    • SOLUTION, METERED
    • SOLUTION, SOLUTION
    • SOLUTION/DROPS
    • SOLUTION; ORAL AND TABLET
    • SOLUTION; TABLET, DELAYED RELEASE
    • SPONGE
    • SPRAY
    • SPRAY, METERED
    • SUPPOSITORY
    • SUSPENSION
    • SUSPENSION, EXTENDED RELEASE
    • SUSPENSION/DROPS
    • SWAB
    • SYRINGE
    • SYRUP
    • SYSTEM
    • SYSTEM, EXTENDED RELEASE
    • TABLET
    • TABLET, CHEWABLE
    • TABLET, CHEWABLE, TABLET
    • TABLET, CHEWABLE, TABLET, CAPSULE
    • TABLET, COATED PARTICLES
    • TABLET, DELAYED RELEASE
    • TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING
    • TABLET, DISPERSIBLE
    • TABLET, EFFERVESCENT
    • TABLET, EXTENDED RELEASE
    • TABLET, EXTENDED RELEASE, CHEWABLE
    • TABLET, FOR SUSPENSION
    • TABLET, ORALLY DISINTEGRATING
    • TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
    • TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
    • TABLET, TABLET
    • TABLET, TABLET, TABLET
    • TAMPON
    • TAPE
    • TREATMENT
    • TROCHE/LOZENGE
    • UNKNOWN
    • VIAL
  • 化学类型
    • Type 1 - New Molecular Entity
    • Type 1 - New Molecular Entity and Type 4 - New Combination
    • Type 2 - New Active Ingredient
    • Type 2 - New Active Ingredient and Type 3 - New Dosage Form
    • Type 2 New Active Ingredient and Type 4 New Combination
    • Type 3 - New Dosage Form
    • Type 3 - New Dosage Form and Type 4 - New Combination
    • Type 4 - New Combination
    • Type 5 - New Formulation or New Manufacturer
    • Type 6 - New Indication (no longer used)
    • Type 7 - Drug Already Marketed without Approved NDA
    • Type 8 - Partial Rx to OTC Switch
  • 市场状态
    • Discontinued
    • None (Tentative Approval)
    • Over-the-counter
    • Prescription
  • 商品名
  • 给药途径
    • BUCCAL
    • BUCCAL, SUBLINGUAL
    • CAPSULE, DELAYED REL PELLETS
    • DELAYED RELEASE
    • DENTAL
    • ENDOCERVICAL
    • ENTERAL
    • EPIDURAL
    • FOR RX COMPOUNDING
    • IM-IV
    • IMPLANTATION
    • INHALATION
    • INHALATION, INJECTION
    • INHALATION, INTRAVENOUS
    • INHALATION, ORAL
    • INJECTION
    • INJECTION, ORAL
    • INJECTION, ORAL, RECTAL
    • INTRA-ANAL
    • INTRA-ARTICULAR
    • INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL
    • INTRACRANIAL
    • INTRADERMAL
    • INTRALYMPHATIC, INTRAUTERINE
    • INTRAMUSCULAR
    • INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS
    • INTRAMUSCULAR, INTRAVENOUS
    • INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    • INTRAMUSCULAR, IV (INFUSION)
    • INTRAMUSCULAR, ORAL
    • INTRAMUSCULAR, SUBCUTANEOUS
    • INTRAOCULAR
    • INTRAPERITONEAL
    • INTRAPLEURAL
    • INTRATHECAL
    • INTRATRACHEAL
    • INTRAUTERINE
    • INTRAVENOUS
    • INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL
    • INTRAVENOUS, INTRAVENOUS
    • INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC
    • INTRAVENOUS, ORAL
    • INTRAVENOUS, SUBCUTANEOUS
    • INTRAVESICAL
    • INTRAVESICAL, URETERAL
    • INTRAVITREAL
    • IONTOPHORESIS
    • IONTOPHORESIS, TOPICAL
    • IONTOPHORESIS, TRANSDERMAL
    • IRRIGATION
    • IRRIGATION, URETHRAL
    • IV (INFUSION)
    • IV (INFUSION), INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS
    • IV (INFUSION), SUBCUTANEOUS
    • IV (INFUSTION), INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL
    • MAC
    • MULTIDOSE
    • N/A
    • NASAL
    • OPHTHALMIC
    • OPHTHALMIC, OTIC
    • ORAL
    • ORAL AND TABLET
    • ORAL SUSPENSION
    • ORAL W/SENSOR
    • ORAL, RECTAL
    • ORAL-20
    • ORAL-21
    • ORAL-28
    • ORAL; DELAYED RELEASE
    • ORALLY DISINTEGRATING
    • OTIC
    • PERFUSION, BILIARY
    • PERFUSION, CARDIAC
    • PERIODONTAL
    • PREPARATION FOR INTRAVENOUS USE
    • RECTAL
    • RECTAL, SUBLINGUAL
    • SINGLE-DOSE
    • SINGLE-USE
    • SINUS
    • SPINAL
    • SUBCUTANEOUS
    • SUBCUTANEOUS LYOPHILIZED POWER
    • SUBLINGUAL
    • SUSPENSION
    • TOPICAL
    • TOPICAL, VAGINAL
    • TRANSMUCOSAL
    • URETERAL
    • URETHRAL
    • VAGINAL
  • 批准日期 -
  • 参比药物
  • 公司
  • 注册审批号
  • 审评分类
    • Orphan
    • PRIORITY
    • PRIORITY;Orphan
    • STANDARD
    • STANDARD;Orphan
  • 参比标准
其他选项:
中国CDE注册与受理 NDA ANDA BLA 全选 药物类型 化学类型 商品名 批准时间 上一页 下一页
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  • 批准日期
  • 活性成分
  • 商品名
  • 公司
  • 注册审批号
  • 剂型
  • 给药途径
  • 规格
  • 化学类型
  • 2019-05-17
  • midazolam
  • nayzilam
  • proximagen llc
  • NDA 211321
  • spray
  • nasal
  • 5mg/0.5ml
  • Type 3 - New Dosage Form
  • 2019-05-17
  • lurasidone hydrochloride
  • lurasidone hydrochloride
  • teva pharms usa
  • ANDA 208060
  • tablet
  • oral
  • 120mg
  • 2019-05-17
  • lurasidone hydrochloride
  • lurasidone hydrochloride
  • teva pharms usa
  • ANDA 208060
  • tablet
  • oral
  • 40mg
  • 2019-05-17
  • lurasidone hydrochloride
  • lurasidone hydrochloride
  • teva pharms usa
  • ANDA 208060
  • tablet
  • oral
  • 80mg
  • 2019-05-17
  • lurasidone hydrochloride
  • lurasidone hydrochloride
  • teva pharms usa
  • ANDA 208060
  • tablet
  • oral
  • 60mg
  • 2019-05-17
  • lurasidone hydrochloride
  • lurasidone hydrochloride
  • teva pharms usa
  • ANDA 208060
  • tablet
  • oral
  • 20mg
  • 2019-05-17
  • cinacalcet hydrochloride
  • cinacalcet hydrochloride
  • alkem labs ltd
  • ANDA 210570
  • tablet
  • oral
  • 90mg
  • 2019-05-17
  • cinacalcet hydrochloride
  • cinacalcet hydrochloride
  • alkem labs ltd
  • ANDA 210570
  • tablet
  • oral
  • 30mg
  • 2019-05-17
  • cinacalcet hydrochloride
  • cinacalcet hydrochloride
  • alkem labs ltd
  • ANDA 210570
  • tablet
  • oral
  • 60mg
  • 2019-05-17
  • amphetamine aspartate;
    amphetamine sulfate;
    dextroamphetamine saccharate;
    dextroamphetamine sulfate
  • amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate
  • sun pharm inds inc
  • ANDA 211715
  • capsule, extended release
  • oral
  • 1.25mg;
    1.25mg;
    1.25mg;
    1.25mg
  • 2019-05-17
  • amphetamine aspartate;
    amphetamine sulfate;
    dextroamphetamine saccharate;
    dextroamphetamine sulfate
  • amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate
  • sun pharm inds inc
  • ANDA 211715
  • capsule, extended release
  • oral
  • 3.75mg;
    3.75mg;
    3.75mg;
    3.75mg
  • 2019-05-17
  • amphetamine aspartate;
    amphetamine sulfate;
    dextroamphetamine saccharate;
    dextroamphetamine sulfate
  • amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate
  • sun pharm inds inc
  • ANDA 211715
  • capsule, extended release
  • oral
  • 6.25mg;
    6.25mg;
    6.25mg;
    6.25mg
  • 2019-05-17
  • amphetamine aspartate;
    amphetamine sulfate;
    dextroamphetamine saccharate;
    dextroamphetamine sulfate
  • amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate
  • sun pharm inds inc
  • ANDA 211715
  • capsule, extended release
  • oral
  • 2.5mg;
    2.5mg;
    2.5mg;
    2.5mg
  • 2019-05-17
  • amphetamine aspartate;
    amphetamine sulfate;
    dextroamphetamine saccharate;
    dextroamphetamine sulfate
  • amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate
  • sun pharm inds inc
  • ANDA 211715
  • capsule, extended release
  • oral
  • 7.5mg;
    7.5mg;
    7.5mg;
    7.5mg
  • 2019-05-17
  • amphetamine aspartate;
    amphetamine sulfate;
    dextroamphetamine saccharate;
    dextroamphetamine sulfate
  • amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate
  • sun pharm inds inc
  • ANDA 211715
  • capsule, extended release
  • oral
  • 5mg;
    5mg;
    5mg;
    5mg
  • 2019-05-15
  • zoledronic acid
  • zoledronic acid
  • shilpa medicare ltd
  • ANDA 208513
  • injectable
  • intravenous
  • eq 4mg base/5ml
  • 2019-05-14
  • albendazole
  • albendazole
  • edenbridge pharms
  • ANDA 211117
  • tablet
  • oral
  • 200mg
  • 2019-05-14
  • glycopyrrolate
  • glycopyrrolate
  • sandoz inc
  • ANDA 211334
  • injectable
  • injection
  • 0.2mg/ml
  • 2019-05-14
  • fulvestrant
  • fulvestrant
  • sandoz inc
  • ANDA 205935
  • injectable
  • intramuscular
  • 50mg/ml
  • 2019-05-13
  • labetalol hydrochloride
  • labetalol hydrochloride
  • cadila pharms ltd
  • ANDA 211325
  • tablet
  • oral
  • 300mg