FDA.reportPublic FDA data

Application 091078

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDESYRUP;ORALEQ 15MG BASE/MLNoNo

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
A091078-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2011-03-22

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 22:54:322026-06A091078-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2011-03-22a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ranitidine HydrochlorideRANITIDINE HYDROCHLORIDEDr. Reddy's Laboratories Limited7bf94bf7-fa11-70be-9f65-fe26a3db5a632018-11-21Adverse reactionsName fallback
brand name: Ranitidine Hydrochloride
generic name: RANITIDINE HYDROCHLORIDE
Acid ReducerRANITIDINE HYDROCHLORIDEWinCo Foods, LLC70bc7062-ab3c-43eb-b524-0d8c6d1a674d2014-12-10WarningsName fallback
generic name: RANITIDINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-051RanitidineRanitidineHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-051RanitidineRanitidineHi-Tech Pharmacal Co., Inc.ANDACurrent