NDC 0268-0192

CENTER-AL - PHLEUM PRATENSE POLLEN

Allergenic Extracts Alum Precipitated

CENTER-AL - PHLEUM PRATENSE POLLEN is a Subcutaneous Injection, Suspension in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Phleum Pratense Pollen.

Product ID0268-0192_2d1dc322-a48a-48b5-a953-5158a1f7a5b3
NDC0268-0192
Product TypeNon-standardized Allergenic
Proprietary NameCENTER-AL - PHLEUM PRATENSE POLLEN
Generic NameAllergenic Extracts Alum Precipitated
Dosage FormInjection, Suspension
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1975-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NamePHLEUM PRATENSE POLLEN
Active Ingredient Strength10000 [PNU]/mL
Pharm ClassesStandardized 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 Through2019-12-31

Packaging

NDC 0268-0192-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0192-10)
Marketing Start Date1975-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-0192-10 [00268019210]

CENTER-AL - PHLEUM PRATENSE POLLEN INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1975-01-15

NDC 0268-0192-30 [00268019230]

CENTER-AL - PHLEUM PRATENSE POLLEN INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1975-01-15

Drug Details

Active Ingredients

IngredientStrength
PHLEUM PRATENSE POLLEN10000 [PNU]/mL

Pharmacological Class

  • 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 "CENTER-AL - PHLEUM PRATENSE POLLEN" or generic name "Allergenic Extracts Alum Precipitated"

NDCBrand NameGeneric Name
0268-0193CENTER-AL - PHLEUM PRATENSE POLLENCENTER-AL - PHLEUM PRATENSE POLLEN
0268-0192CENTER-AL - PHLEUM PRATENSE POLLENCENTER-AL - PHLEUM PRATENSE POLLEN
0268-0021CENTER-AL - ACACIA LONGIFOLIA POLLENAllergenic Extracts Alum Precipitated
0268-0047CENTER-AL - ACER NEGUNDO POLLENAllergenic Extracts Alum Precipitated
0268-0100CENTER-AL - ACER SACCHARUM POLLENAllergenic Extracts Alum Precipitated
0268-0024CENTER-AL - ALNUS INCANA SSP. RUGOSA POLLENAllergenic Extracts Alum Precipitated
0268-0140CENTER-AL - AMARANTHUS RETROFLEXUS POLLENAllergenic Extracts Alum Precipitated
0268-0141CENTER-AL - AMARANTHUS RETROFLEXUS POLLENAllergenic Extracts Alum Precipitated
0268-0110CENTER-AL - ARTEMISIA VULGARIS POLLENAllergenic Extracts Alum Precipitated
0268-0125CENTER-AL - AVENA SATIVA POLLENAllergenic Extracts Alum Precipitated
0268-0041CENTER-AL - BETULA LENTA POLLENAllergenic Extracts Alum Precipitated
0268-0050CENTER-AL - BROMUS INERMIS POLLENAllergenic Extracts Alum Precipitated
0268-0137CENTER-AL - CARYA ILLINOINENSIS POLLENAllergenic Extracts Alum Precipitated
0268-0078CENTER-AL - CARYA OVATA POLLENAllergenic Extracts Alum Precipitated
0268-0097CENTER-AL - CHENOPODIUM ALBUM POLLENAllergenic Extracts Alum Precipitated
0268-0075CENTER-AL - CORYLUS AMERICANA POLLENAllergenic Extracts Alum Precipitated
0268-0037CENTER-AL - CYNODON DACTYLON POLLENAllergenic Extracts Alum Precipitated
0268-0038CENTER-AL - CYNODON DACTYLON POLLENAllergenic Extracts Alum Precipitated
0268-0134CENTER-AL - DACTYLIS GLOMERATA POLLENAllergenic Extracts Alum Precipitated
0268-0034CENTER-AL - FAGUS GRANDIFOLIA POLLENAllergenic Extracts Alum Precipitated
0268-0103CENTER-AL - FESTUCA PRATENSIS POLLENAllergenic Extracts Alum Precipitated
0268-0104CENTER-AL - FESTUCA PRATENSIS POLLENAllergenic Extracts Alum Precipitated
0268-0027CENTER-AL - FRAXINUS AMERICANA POLLENAllergenic Extracts Alum Precipitated
0268-0094CENTER-AL - KOCHIA SCOPARIA POLLENAllergenic Extracts Alum Precipitated
0268-0113CENTER-AL - MORUS RUBRA POLLENAllergenic Extracts Alum Precipitated
0268-0128CENTER-AL - OLEA EUROPAEA POLLENAllergenic Extracts Alum Precipitated
0268-0129CENTER-AL - OLEA EUROPAEA POLLENAllergenic Extracts Alum Precipitated
0268-0130CENTER-AL - OLEA EUROPAEA POLLENAllergenic Extracts Alum Precipitated
0268-0131CENTER-AL - OLEA EUROPAEA POLLENAllergenic Extracts Alum Precipitated
0268-0030CENTER-AL - PASPALUM NOTATUM POLLENAllergenic Extracts Alum Precipitated
0268-0031CENTER-AL - PASPALUM NOTATUM POLLENAllergenic Extracts Alum Precipitated
0268-0144CENTER-AL - PLANTAGO LANCEOLATA POLLENAllergenic Extracts Alum Precipitated
0268-0145CENTER-AL - PLANTAGO LANCEOLATA POLLENAllergenic Extracts Alum Precipitated
0268-0146CENTER-AL - PLANTAGO LANCEOLATA POLLENAllergenic Extracts Alum Precipitated
0268-0147CENTER-AL - PLANTAGO LANCEOLATA POLLENAllergenic Extracts Alum Precipitated
0268-0044CENTER-AL - POA ANNUA POLLENAllergenic Extracts Alum Precipitated
0268-0090CENTER-AL - POA PRATENSIS POLLENAllergenic Extracts Alum Precipitated
0268-0091CENTER-AL - POA PRATENSIS POLLENAllergenic Extracts Alum Precipitated
0268-0150CENTER-AL - POPULUS ALBA POLLENAllergenic Extracts Alum Precipitated
0268-0060CENTER-AL - POPULUS DELTOIDES SSP. MONILIFERA POLLENAllergenic Extracts Alum Precipitated
0268-0107CENTER-AL - PROSOPIS JULIFLORA POLLENAllergenic Extracts Alum Precipitated
0268-0116CENTER-AL - QUERCUS AGRIFOLIA POLLENAllergenic Extracts Alum Precipitated
0268-0122CENTER-AL - QUERCUS ALBA POLLENAllergenic Extracts Alum Precipitated
0268-0119CENTER-AL - QUERCUS VIRGINIANA POLLENAllergenic Extracts Alum Precipitated
0268-0063CENTER-AL - RUMEX ACETOSELLA POLLENAllergenic Extracts Alum Precipitated
0268-0066CENTER-AL - RUMEX CRISPUS POLLENAllergenic Extracts Alum Precipitated
0268-0087CENTER-AL - SORGHUM HALEPENSE POLLENAllergenic Extracts Alum Precipitated
0268-0069CENTER-AL - ULMUS AMERICANA POLLENAllergenic Extracts Alum Precipitated
0268-0072CENTER-AL - ULMUS PUMILA POLLENAllergenic Extracts Alum Precipitated
0268-0053CENTER-AL - XANTHIUM STRUMARIUM POLLENAllergenic Extracts Alum Precipitated

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