NDC 65044-3674

Food - Fish and Shellfish, Tuna Thunnus sp.

Tuna Thunnus Sp.

Food - Fish and Shellfish, Tuna Thunnus 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 Tuna, Unspecified.

Product ID65044-3674_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c
NDC65044-3674
Product TypeNon-standardized Allergenic
Proprietary NameFood - Fish and Shellfish, Tuna Thunnus sp.
Generic NameTuna Thunnus Sp.
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1941-04-19
Marketing CategoryBLA / BLA
Application NumberBLA103888
Labeler NameJubilant HollisterStier LLC
Substance NameTUNA, UNSPECIFIED
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65044-3674-2

10 mL in 1 VIAL (65044-3674-2)
Marketing Start Date1941-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-3674-2 [65044367402]

Food - Fish and Shellfish, Tuna Thunnus sp. INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103888
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1941-04-19

Drug Details

Active Ingredients

IngredientStrength
TUNA, UNSPECIFIED.1 g/mL

Pharmacological Class

  • Non-Standardized Food Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Allergens [CS]
  • Dietary Proteins [CS]
  • Fish Proteins
  • Dietary [EXT]

NDC Crossover Matching brand name "Food - Fish and Shellfish, Tuna Thunnus sp." or generic name "Tuna Thunnus Sp."

NDCBrand NameGeneric Name
65044-3674Food - Fish and Shellfish, Tuna Thunnus sp.Tuna Thunnus sp.
65044-3675Food - Fish and Shellfish, Tuna Thunnus sp.Tuna Thunnus sp.

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