FDA.reportPublic FDA data

Application 080455

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
007MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/MLNoNo
008MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoNo
009MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION75MG/MLNoNo
010MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION100MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080455-007MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONAPApproved before 1982
A080455-008MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPApproved before 1982
A080455-009MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE75MG/MLINJECTABLE / INJECTIONAPApproved before 1982
A080455-010MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A080455-007AP
A080455-008AP
A080455-009AP
A080455-010AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A080455-007MEPERIDINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONAPApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A080455-008MEPERIDINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A080455-009MEPERIDINE HYDROCHLORIDE75MG/MLINJECTABLE / INJECTIONAPApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A080455-010MEPERIDINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAPApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A080455-007AP1a50c72e98297…
2026-08-01 22:54:322026-06A080455-008AP1a50c72e98297…
2026-08-01 22:54:322026-06A080455-009AP1a50c72e98297…
2026-08-01 22:54:322026-06A080455-010AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.b31d1308-28c3-43f4-e0a6-2f3ed76b89752026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEPERIDINE HYDROCHLORIDE
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.15bc51a8-1e24-4d33-9a2f-05a41c29acf02026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Meperidine Hydrochloride
generic name: MEPERIDINE HYDROCHLORIDE
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEGenus Lifesciences Inc.792fefda-6cc4-4709-b902-fd9787fc310a2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Meperidine Hydrochloride
generic name: MEPERIDINE HYDROCHLORIDE
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEEPIC PHARMA, LLCfae5cc34-5917-4445-9516-25f97ffca8db2025-11-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Meperidine Hydrochloride
generic name: MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e0e998da-f056-4fce-be8e-ed60cf3b461b2024-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MEPERIDINE HYDROCHLORIDE
generic name: MEPERIDINE HYDROCHLORIDE