FDA.reportPublic FDA data

Application 210243

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 150MG BASENoNo
002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 150MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210243-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20
A210243-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20

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 22:54:322026-06A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20a50c72e98297…
2026-08-01 22:54:322026-06A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RanitidineRANITIDINEGranules India Ltdaab81d9f-397d-49fb-8083-77a1872cc71f2025-12-02WarningsExact identifier
application applno (ANDA): 210243
application number: ANDA210243
ndc (product): 62207-773
ndc (product): 62207-774

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
37808-196Acid ReducerRanitidineHEBANDACurrent
50268-721RanitidineRanitidineAvPAKANDACurrent
62207-773RanitidineRanitidineGranules India LtdANDACurrent
62207-773RanitidineRanitidineGranules India LtdANDACurrent
62207-773RanitidineRanitidineGranules India LtdANDACurrent
62207-773RanitidineRanitidineGranules India LtdANDACurrent
62207-773RanitidineRanitidineGranules India LtdANDACurrent
62207-773RanitidineRanitidineGranules India LtdANDACurrent
62207-774RanitidineRanitidineGranules India LtdANDACurrent
62207-774RanitidineRanitidineGranules India LtdANDACurrent
62207-774RanitidineRanitidineGranules India LtdANDACurrent
62207-774RanitidineRanitidineGranules India LtdANDACurrent
62207-774RanitidineRanitidineGranules India LtdANDACurrent
62207-774RanitidineRanitidineGranules India LtdANDACurrent
69168-397Ranitidine 150Ranitidine HCl Tablets 150mgAllegiant HealthANDACurrent
69168-397Ranitidine 150Ranitidine HCl Tablets 150mgAllegiant HealthANDACurrent