NDC 43598-097

JAVYGTOR

Sapropterin Dihydrochloride

JAVYGTOR is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddys Laboratories Inc. The primary component is Sapropterin Dihydrochloride.

Product ID43598-097_ecb86af2-3917-0f6e-b88c-b869f7350c0a
NDC43598-097
Product TypeHuman Prescription Drug
Proprietary NameJAVYGTOR
Generic NameSapropterin Dihydrochloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2022-09-16
Marketing CategoryANDA /
Application NumberANDA209452
Labeler NameDr. Reddys Laboratories Inc
Substance NameSAPROPTERIN DIHYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesBreast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 43598-097-30

30 PACKET in 1 CARTON (43598-097-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11)
Marketing Start Date2022-09-16
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "JAVYGTOR" or generic name "Sapropterin Dihydrochloride"

NDCBrand NameGeneric Name
43598-097JAVYGTORSapropterin Dihydrochloride
68135-300KuvanSAPROPTERIN DIHYDROCHLORIDE
68135-301KuvanSAPROPTERIN DIHYDROCHLORIDE
68135-482Kuvansapropterin dihydrochloride
43598-477Sapropterin DihydrochlorideSapropterin Dihydrochloride
43598-749Sapropterin DihydrochlorideSapropterin Dihydrochloride
49884-720sapropterin dihydrochloridesapropterin dihydrochloride
49884-873SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE
49884-948SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE

Trademark Results [JAVYGTOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
JAVYGTOR
JAVYGTOR
97434525 not registered Live/Pending
Cycle Pharmaceuticals Ltd
2022-05-30

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