NDC 52709-1701

Odactra

Dermatophagoides Pteronyssinus And Dermatophagoides Farinae

Odactra is a Sublingual Tablet in the Standardized Allergenic category. It is labeled and distributed by Alk-abello A S. The primary component is Dermatophagoides Pteronyssinus; Dermatophagoides Farinae.

Product ID52709-1701_0b7229a0-4606-42a6-aabb-0de8f5a9c0dd
NDC52709-1701
Product TypeStandardized Allergenic
Proprietary NameOdactra
Generic NameDermatophagoides Pteronyssinus And Dermatophagoides Farinae
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2018-01-01
Marketing CategoryBLA / BLA
Application NumberBLA125592
Labeler NameALK-Abello A S
Substance NameDERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE
Active Ingredient Strength6 [arb'U]/1; [arb'U]/1
Pharm ClassesStandardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 52709-1701-3

3 BLISTER PACK in 1 CARTON (52709-1701-3) > 10 TABLET in 1 BLISTER PACK (52709-1701-1)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52709-1701-1 [52709170101]

Odactra TABLET
Marketing CategoryBLA
Application NumberBLA125592
Product TypeSTANDARDIZED ALLERGENIC
Billing UnitEA
Marketing Start Date2018-01-01

NDC 52709-1701-3 [52709170103]

Odactra TABLET
Marketing CategoryBLA
Application NumberBLA125592
Product TypeSTANDARDIZED ALLERGENIC
Billing UnitEA
Marketing Start Date2018-01-01

NDC 52709-1701-5 [52709170105]

Odactra TABLET
Marketing CategoryBLA
Application NumberBLA125592
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date2018-01-01

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS6 [arb'U]/1

Pharmacological Class

  • Standardized Insect Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Antigens
  • Dermatophagoides [CS]
  • Insect Proteins [CS]
  • Allergens [CS]
  • Allergens [CS]
  • Insect Proteins [CS]
  • Standardized Insect Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Antigens
  • Dermatophagoides [CS]

Trademark Results [Odactra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ODACTRA
ODACTRA
86821128 5387196 Live/Registered
ALK-ABELLÓ A/S
2015-11-16
ODACTRA
ODACTRA
77737096 3955335 Dead/Cancelled
MERCK SHARP & DOHME CORP.
2009-05-14
ODACTRA
ODACTRA
76635194 not registered Dead/Abandoned
Merck & Co., Inc.
2005-04-05

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