NDC 0268-8070

OAK MIX

Quercus Alba Pollen, Quercus Rubra Pollen And Quercus Virginiana Pollen

OAK MIX is a Percutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Quercus Rubra Pollen; Quercus Alba Pollen; Quercus Virginiana Pollen.

Product ID0268-8070_1bfa47a1-680f-4c15-9cd6-fd71c98f8c0c
NDC0268-8070
Product TypeNon-standardized Allergenic
Proprietary NameOAK MIX
Generic NameQuercus Alba Pollen, Quercus Rubra Pollen And Quercus Virginiana Pollen
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameQUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; QUERCUS VIRGINIANA POLLEN
Active Ingredient Strength0 g/mL; g/mL; g/mL
Pharm ClassesNon-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0268-8070-10

10.5 mL in 1 VIAL (0268-8070-10)
Marketing Start Date1998-02-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-8070-50 [00268807050]

OAK MIX INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1998-02-23

NDC 0268-8070-06 [00268807006]

OAK MIX INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

NDC 0268-8070-10 [00268807010]

OAK MIX INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1998-02-23

Drug Details

Active Ingredients

IngredientStrength
QUERCUS RUBRA POLLEN.05 g/mL

Pharmacological Class

  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]

NDC Crossover Matching brand name "OAK MIX" or generic name "Quercus Alba Pollen, Quercus Rubra Pollen And Quercus Virginiana Pollen"

NDCBrand NameGeneric Name
0268-8070OAK MIXQUERCUS ALBA POLLEN, QUERCUS RUBRA POLLEN and QUERCUS VIRGINIANA POLLEN
65044-2035Pollens - Trees, Oak MixOak Mix
65044-2036Pollens - Trees, Oak MixOak Mix
65044-2037Pollens - Trees, Oak MixOak Mix
65044-2038Pollens - Trees, Oak MixOak Mix
65044-2039Pollens - Trees, Oak MixOak Mix

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