FDA.reportPublic FDA data

Application 200536

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A200536-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2011-06-28

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A200536-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2011-06-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200536-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2011-06-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200536-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2011-06-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A200536-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2011-06-28a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0362Wal-ZanRanitidineWalgreen CompanyANDACurrent
0904-6350Acid ReducerRanitidineMajor PharmaceuticalsANDACurrent
15127-340Acid ReducerRanitidineSelect BrandANDACurrent
37012-351RanitidineRanitidineShopko Stores Operating Co., LLCANDACurrent
37808-351Acid ReducerRanitidineH E BANDACurrent
41163-351EqualineRanitidineSupervalu Inc.ANDACurrent
49035-351Acid ReducerRanitidineWal-Mart Stores, IncANDACurrent
49348-026acid reducerRanitidineMcKessonANDACurrent
49781-027Acid ReducerRanitidineCardinal HealthANDACurrent
51660-351Acid ReducerRanitidineOhm Laboratories Inc.ANDACurrent
53329-695RanitidineRanitidineMedline Industries, Inc.ANDACurrent
55315-351Acid ReducerRanitidineFred's Inc.ANDACurrent
55319-351Regular Strength Acid ReducerRanitidineFamily DollarANDACurrent
57910-404RanitidineRanitidineShasun Pharmaceuticals LimitedANDACurrent
59779-354ACID REDUCERRanitidineCVS PharmacyANDACurrent
61715-089Acid ReducerRanitidinePreferred Plus (Kinray)ANDACurrent
62011-0227acid reducerRanitidineMcKessonANDACurrent
63868-487ACID REDUCERRanitidineChain Drug Marketing Association Inc.ANDACurrent
63941-351ACID REDUCERRanitidine HydrochlorideValu Merchandisers CompanyANDACurrent
67091-243Acid ReducerRanitidineWinCo Foods, LLCANDACurrent
68016-351Acid ReducerRanitidinePremier ValueANDACurrent