NDC 65044-3020

Food - Plant Source, Apple Malus sp.

Apple Malus Sp.

Food - Plant Source, Apple Malus sp. is a Percutaneous; Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Apple.

Product ID65044-3020_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c
NDC65044-3020
Product TypeNon-standardized Allergenic
Proprietary NameFood - Plant Source, Apple Malus sp.
Generic NameApple Malus Sp.
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1941-04-19
Marketing CategoryBLA / BLA
Application NumberBLA103888
Labeler NameJubilant HollisterStier LLC
Substance NameAPPLE
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65044-3020-2

10 mL in 1 VIAL (65044-3020-2)
Marketing Start Date1941-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-3020-2 [65044302002]

Food - Plant Source, Apple Malus sp. INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103888
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1941-04-19

Drug Details

Active Ingredients

IngredientStrength
APPLE.1 g/mL

Pharmacological Class

  • Non-Standardized Food Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Allergens [CS]
  • Dietary Proteins [CS]
  • Fruit Proteins [EXT]

NDC Crossover Matching brand name "Food - Plant Source, Apple Malus sp." or generic name "Apple Malus Sp."

NDCBrand NameGeneric Name
65044-3020Food - Plant Source, Apple Malus sp.Apple Malus sp.
65044-3021Food - Plant Source, Apple Malus sp.Apple Malus sp.

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