FDA.reportPublic FDA data

Application 074252

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIMETIDINE HYDROCHLORIDECIMETIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 300MG BASE/2MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074252-001CIMETIDINE HYDROCHLORIDECIMETIDINE HYDROCHLORIDEEQ 300MG BASE/2MLINJECTABLE / INJECTION1997-11-26

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 22:54:322026-06A074252-001CIMETIDINE HYDROCHLORIDEEQ 300MG BASE/2MLINJECTABLE / INJECTION1997-11-26a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CIMETIDINE HYDROCHLORIDECIMETIDINE HYDROCHLORIDEChartwell RX, LLCd1d73350-4e7e-428a-90a5-6000fd373a4f2026-02-05Adverse reactionsName fallback
brand name: CIMETIDINE HYDROCHLORIDE
generic name: CIMETIDINE HYDROCHLORIDE
CIMETIDINE HYDROCHLORIDECIMETIDINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.e40bb1f6-338a-42e7-9217-8c32d14ccfd32025-11-04Adverse reactionsName fallback
brand name: CIMETIDINE HYDROCHLORIDE
generic name: CIMETIDINE HYDROCHLORIDE
Cimetidine HydrochlorideCIMETIDINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmab8b50bd9-bc1b-4da5-96c5-8eb917c8937f2025-01-06Adverse reactionsName fallback
brand name: Cimetidine Hydrochloride
generic name: CIMETIDINE HYDROCHLORIDE