NDC 68083-202

Temsirolimus

Temsirolimus Injection

Temsirolimus is a Kit in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is .

Product ID68083-202_45d15ea9-1902-49de-9c84-6ef8ee60bf14
NDC68083-202
Product TypeHuman Prescription Drug
Proprietary NameTemsirolimus
Generic NameTemsirolimus Injection
Dosage FormKit
Marketing Start Date2019-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA207383
Labeler NameGland Pharma Limited
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-202-01

1 KIT in 1 CARTON (68083-202-01) * 1 mL in 1 VIAL, SINGLE-USE (68083-200-01) * 1.8 mL in 1 VIAL, SINGLE-USE (68083-201-01)
Marketing Start Date2019-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-202-01 [68083020201]

Temsirolimus KIT
Marketing CategoryANDA
Application NumberANDA207383
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-26

Drug Details

OpenFDA Data

SPL SET ID:d7ee3165-175d-4439-8740-fbfed18aaf0e
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 722289
  • NDC Crossover Matching brand name "Temsirolimus" or generic name "Temsirolimus Injection"

    NDCBrand NameGeneric Name
    16729-223Temsirolimustemsirolimus
    65219-200TemsirolimusTemsirolimus
    68083-202TemsirolimusTemsirolimus Injection
    72611-785TemsirolimusTemsirolimus Injection
    0008-1179Toriseltemsirolimus

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