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Insects (Whole Body), Mite Dermatophagoides pteronyssinus Purple Book BLA 101835

BLA number
101835
Proper names
Insects (Whole Body), Mite Dermatophagoides pteronyssinus
Applicant
Greer Laboratories, Inc.
Center
CBER
First observed release
2020-08-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)10,000AU/MLInjectionPercutaneousDropper VialRxLicensed1958-09-15
002Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)5,000AU/MLInjectionIntradermalMulti-Dose VialRxLicensed1958-09-15
003Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)5,000AU/MLInjectionSubcutaneousMulti-Dose VialRxLicensed1958-09-15
004Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)10,000AU/MLInjectionIntradermalMulti-Dose VialRxLicensed1958-09-15
005Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)10,000AU/MLInjectionSubcutaneousMulti-Dose VialRxLicensed1958-09-15
006Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)30,000AU/MLInjectionIntradermalMulti-Dose VialRxLicensed1958-09-15
007Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)30,000AU/MLInjectionSubcutaneousMulti-Dose VialRxLicensed1958-09-15

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2021-05-01U001Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2021-05-01U002Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2021-05-01U003Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2021-05-01U004Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2021-05-01U005Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2021-05-01U006Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2021-05-01U007Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2020-08-01R001Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2020-08-01R002Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2020-08-01R003Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2020-08-01R004Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2020-08-01R005Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2020-08-01R006Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.
2020-08-01R007Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxGreer Laboratories, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-08-01001Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxLicensed1958-09-15
2020-08-01002Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxLicensed1958-09-15
2020-08-01003Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxLicensed1958-09-15
2020-08-01004Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxLicensed1958-09-15
2020-08-01005Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxLicensed1958-09-15
2020-08-01006Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxLicensed1958-09-15
2020-08-01007Insects (Whole Body), Mite Dermatophagoides pteronyssinus351(a)RxLicensed1958-09-15