NDC 36987-1265

Smelt

Smelt

Smelt is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Smelt.

Product ID36987-1265_398aea37-e253-4fd4-84ca-ca78367468b5
NDC36987-1265
Product TypeHuman Prescription Drug
Proprietary NameSmelt
Generic NameSmelt
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameSMELT
Active Ingredient Strength0 g/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-1265-3

30 mL in 1 VIAL, MULTI-DOSE (36987-1265-3)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1265-3 [36987126503]

Smelt INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-1265-2 [36987126502]

Smelt INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-1265-4 [36987126504]

Smelt INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-1265-1 [36987126501]

Smelt INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
SMELT.1 g/mL

OpenFDA Data

SPL SET ID:026f2f1e-71cf-47ab-a24d-66663ff98429
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905479
  • 892506
  • 905345
  • 892564
  • 904543
  • 901282
  • 892595
  • 892546
  • 966805
  • 899433
  • 966978
  • 901375
  • 904599
  • 901290
  • 899751
  • 899937
  • 905489
  • 901397
  • 905329
  • 892542
  • 905365
  • 892613
  • NDC Crossover Matching brand name "Smelt" or generic name "Smelt"

    NDCBrand NameGeneric Name
    36987-1262SmeltSmelt
    36987-1263SmeltSmelt
    36987-1264SmeltSmelt
    36987-1265SmeltSmelt

    Trademark Results [Smelt]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SMELT
    SMELT
    90627710 not registered Live/Pending
    Blossom LLC
    2021-04-06

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.