2024年3月16日发(作者：性飞语)
APPLICATION
NUMBER
NDA
208746(1)
NDA 206610
NDA 214313
NDA 204803
NDA 204957
NDA 212994
NDA 211844
NDA 213072
NDA 214154
NDA 212045
NDA
214657(1)
NDA 211988
NDA 214253
NDA 211488
NDA 214846
NDA 213378
NDA 215025
NDA 213218
NDA 213536
PROPRIETARY NAME
NOREPINEPHRINE
BITARTRATE IN 5%
DEXTROSE
POSIMIR
AZSTARYS
ROSZET
NEXTSTELLIS
KLOXXADO
PEMETREXED
ZYNRELEF
LEVOTHYROXINE
SODIUM
CAMCEVI
MYFEMBREE
LYBALVI
SOAANZ
REZIPRES
ESTABLISHED NAME通用名APPLICANT
PEMETREXED培美曲塞HOSPIRA INC
ACETAMINOPHEN对乙酰氨基酚RISING
NOREPINEPHRINE酒石酸去甲肾上腺BAXTER HEALTHCARE
BITARTRATE素CORP
BUPIVACAINE布比卡因DURECT CORP
ACETAMINOPHEN对乙酰氨基酚
B BRAUN MEDICAL
INC
SERDEXMETHYLPHENID
ATE AND
对甲苯磺酸盐和对COMMAVE
DEXMETHYLPHENIDATE
甲苯磺酸盐THERAPEUTICS SA
MIDAZOLAM咪达唑仑INFORLIFE SA
ROSUVASTATIN AND瑞舒伐他汀和依折
ALTHERA
EZETIMIBE麦布
PHARMACEUTICALS
LLC
DROSPIRENONE AND
ESTETROL TABLETS
屈螺酮和雌醇片MAYNE PHARMA LLC
HIKMA
NALOXONE HCL盐酸纳洛酮PHARMACEUTICALS
USA INC
SANDOZ INC
BUPIVACAINE AND布比卡因和美洛昔HERON THERAPEUTICS
MELOXICAM康INC
CUSTOPHARM INC
FORESEE
LEUPROLIDE亮丙瑞林PHARMACEUTICALS CO
LTD
RELUGOLIX 40 MG,
ESTRADIOL 1 MG,
RELUGOLIX 40 mg
AND NORETHINDRONE
、雌二醇 1 mg 和
MYOVANT SCIENCES
ACETATE 0.5MG
醋酸炔诺酮0.5 mg
GMBH
OLANZAPINE AND
SAMIDORPHAN
奥氮平和沙美芬ALKERMES INC
SODIUM
PHENYLACETATE AND
苯乙酸钠和苯甲酸
MAIA
SODIUM BENZOATE
钠
PHARMACEUTICALS
INC
SARFEZ
TORSEMIDE托拉塞米PHARMACEUTICALS
INC
EPHEDRINE
ETON
HYDROCHLORIDE
盐酸麻黄碱PHARMACEUTICALS
INC
NDA 212156
NDA 210282
NDA 214965
NDA
212303(1)
NDA 214902
NDA 215143
NDA 210735
NDA 213895
NDA 214826
NDA
211566(1)
NDA 213436
NDA 215133
NDA 212854
NDA 213426
NDA 213978
NDA 211950
NDA 214028
NDA 210526
NDA
213005(1)
NDA 214679
NDA 214869
VERKAZIA
TWYNEO
LOREEV XR
TRUDHESA
ZIMHI
SEGLENTIS
TYRVAYA
XIPERE
VUITY
DYANAVEL XR
YUTREPIA
EPRONTIA
DHIVY
MICAFUNGIN
DAPTOMYCIN
CYCLOSPORINE
DULUTEGRAVIR,
LAMIVUDINE, AND
TENOFOVIR
DISOPROXIL
TRETINOIN AND
BENZOYL PEROXIDE
SUCCINYLCHOLINE
CHLORIDE
CYCLOPHOSPHAMIDE
VANCOMYCIN
LORAZEPAM
SITAGLIPTIN
DIHYDROERGOTAMINE
MESYLATE
SERTRALINE
HYDROCHLORIDE
NALOXONE
HYDROCHLORIDE
CELECOXIB AND
TRAMADOL
HYDROCHLORIDE
VARENICLINE
SOLUTION
TRIAMCINOLONE
ACETONIDE
PILOCARPINE
HYDROCHLORIDE
AMPHETAMINE
TREPROSTINIL
TOPIRAMATE
CARBIDOPA AND
LEVODOPA
米卡芬净
PAR STERILE
PRODUCTS LLC
达托霉素HOSPIRA INC
环孢素SANTEN INC
度替拉韦、拉米夫
定和富马酸替诺福LUPIN LTD
韦酯
维 A 酸和过氧化SOL-GEL
苯甲酰TECHNOLOGIES LTD
HIKMA
琥珀胆碱氯化物PHARMACEUTICALS
USA INC
环磷酰胺
EUGIA PHARMA
SPECIALITIES LTD
XELLIA
万古霉素PHARMACEUTICALS
APS
劳拉西泮
ALMATICA PHARMA
LLC
西他列汀
ZYDUS WORLDWIDE
DMCC
甲磺酸二氢麦角胺IMPEL NEUROPHARMA
盐酸舍曲林
ALMATICA PHARMA
LLC
ADAMIS
盐酸纳洛酮PHARMACEUTICALS
CORP
塞来昔布和盐酸曲
KOWA
马多
PHARMACEUTICALS
AMERICA INC
伐尼克兰溶液
OYSTER POINT
PHARMA INC
曲安奈德
BAUSCH AND LOMB
INC
盐酸匹洛卡品ABBVIE INC
安非他明TRIS PHARMA INC
曲前列尼尔
LIQUIDIA
TECHNOLOGIES
AZURITY
托吡酯PHARMACEUTICALS
INC
CARBIDOPA 和左旋
AVION
多巴
PHARMACEUTICALS
LLC
2024年3月16日发(作者：性飞语)
APPLICATION
NUMBER
NDA
208746(1)
NDA 206610
NDA 214313
NDA 204803
NDA 204957
NDA 212994
NDA 211844
NDA 213072
NDA 214154
NDA 212045
NDA
214657(1)
NDA 211988
NDA 214253
NDA 211488
NDA 214846
NDA 213378
NDA 215025
NDA 213218
NDA 213536
PROPRIETARY NAME
NOREPINEPHRINE
BITARTRATE IN 5%
DEXTROSE
POSIMIR
AZSTARYS
ROSZET
NEXTSTELLIS
KLOXXADO
PEMETREXED
ZYNRELEF
LEVOTHYROXINE
SODIUM
CAMCEVI
MYFEMBREE
LYBALVI
SOAANZ
REZIPRES
ESTABLISHED NAME通用名APPLICANT
PEMETREXED培美曲塞HOSPIRA INC
ACETAMINOPHEN对乙酰氨基酚RISING
NOREPINEPHRINE酒石酸去甲肾上腺BAXTER HEALTHCARE
BITARTRATE素CORP
BUPIVACAINE布比卡因DURECT CORP
ACETAMINOPHEN对乙酰氨基酚
B BRAUN MEDICAL
INC
SERDEXMETHYLPHENID
ATE AND
对甲苯磺酸盐和对COMMAVE
DEXMETHYLPHENIDATE
甲苯磺酸盐THERAPEUTICS SA
MIDAZOLAM咪达唑仑INFORLIFE SA
ROSUVASTATIN AND瑞舒伐他汀和依折
ALTHERA
EZETIMIBE麦布
PHARMACEUTICALS
LLC
DROSPIRENONE AND
ESTETROL TABLETS
屈螺酮和雌醇片MAYNE PHARMA LLC
HIKMA
NALOXONE HCL盐酸纳洛酮PHARMACEUTICALS
USA INC
SANDOZ INC
BUPIVACAINE AND布比卡因和美洛昔HERON THERAPEUTICS
MELOXICAM康INC
CUSTOPHARM INC
FORESEE
LEUPROLIDE亮丙瑞林PHARMACEUTICALS CO
LTD
RELUGOLIX 40 MG,
ESTRADIOL 1 MG,
RELUGOLIX 40 mg
AND NORETHINDRONE
、雌二醇 1 mg 和
MYOVANT SCIENCES
ACETATE 0.5MG
醋酸炔诺酮0.5 mg
GMBH
OLANZAPINE AND
SAMIDORPHAN
奥氮平和沙美芬ALKERMES INC
SODIUM
PHENYLACETATE AND
苯乙酸钠和苯甲酸
MAIA
SODIUM BENZOATE
钠
PHARMACEUTICALS
INC
SARFEZ
TORSEMIDE托拉塞米PHARMACEUTICALS
INC
EPHEDRINE
ETON
HYDROCHLORIDE
盐酸麻黄碱PHARMACEUTICALS
INC
NDA 212156
NDA 210282
NDA 214965
NDA
212303(1)
NDA 214902
NDA 215143
NDA 210735
NDA 213895
NDA 214826
NDA
211566(1)
NDA 213436
NDA 215133
NDA 212854
NDA 213426
NDA 213978
NDA 211950
NDA 214028
NDA 210526
NDA
213005(1)
NDA 214679
NDA 214869
VERKAZIA
TWYNEO
LOREEV XR
TRUDHESA
ZIMHI
SEGLENTIS
TYRVAYA
XIPERE
VUITY
DYANAVEL XR
YUTREPIA
EPRONTIA
DHIVY
MICAFUNGIN
DAPTOMYCIN
CYCLOSPORINE
DULUTEGRAVIR,
LAMIVUDINE, AND
TENOFOVIR
DISOPROXIL
TRETINOIN AND
BENZOYL PEROXIDE
SUCCINYLCHOLINE
CHLORIDE
CYCLOPHOSPHAMIDE
VANCOMYCIN
LORAZEPAM
SITAGLIPTIN
DIHYDROERGOTAMINE
MESYLATE
SERTRALINE
HYDROCHLORIDE
NALOXONE
HYDROCHLORIDE
CELECOXIB AND
TRAMADOL
HYDROCHLORIDE
VARENICLINE
SOLUTION
TRIAMCINOLONE
ACETONIDE
PILOCARPINE
HYDROCHLORIDE
AMPHETAMINE
TREPROSTINIL
TOPIRAMATE
CARBIDOPA AND
LEVODOPA
米卡芬净
PAR STERILE
PRODUCTS LLC
达托霉素HOSPIRA INC
环孢素SANTEN INC
度替拉韦、拉米夫
定和富马酸替诺福LUPIN LTD
韦酯
维 A 酸和过氧化SOL-GEL
苯甲酰TECHNOLOGIES LTD
HIKMA
琥珀胆碱氯化物PHARMACEUTICALS
USA INC
环磷酰胺
EUGIA PHARMA
SPECIALITIES LTD
XELLIA
万古霉素PHARMACEUTICALS
APS
劳拉西泮
ALMATICA PHARMA
LLC
西他列汀
ZYDUS WORLDWIDE
DMCC
甲磺酸二氢麦角胺IMPEL NEUROPHARMA
盐酸舍曲林
ALMATICA PHARMA
LLC
ADAMIS
盐酸纳洛酮PHARMACEUTICALS
CORP
塞来昔布和盐酸曲
KOWA
马多
PHARMACEUTICALS
AMERICA INC
伐尼克兰溶液
OYSTER POINT
PHARMA INC
曲安奈德
BAUSCH AND LOMB
INC
盐酸匹洛卡品ABBVIE INC
安非他明TRIS PHARMA INC
曲前列尼尔
LIQUIDIA
TECHNOLOGIES
AZURITY
托吡酯PHARMACEUTICALS
INC
CARBIDOPA 和左旋
AVION
多巴
PHARMACEUTICALS
LLC