FDA.reportPublic FDA data

Application 201745

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 75MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A201745-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acid ReducerRANITIDINE HYDROCHLORIDEWinCo Foods, LLC70bc7062-ab3c-43eb-b524-0d8c6d1a674d2014-12-10WarningsExact identifier
application applno (ANDA): 201745
application number: ANDA201745
ndc (product): 67091-244

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0352RanitidineRanitidineWalgreen CompanyANDACurrent
0904-6349RanitidineRanitidineMajor PharmaceuticalsANDACurrent
15127-711Ranitidine HydrochlorideRanitidine HydrochlorideSelect BrandANDACurrent
21130-003Acid ReducerRanitidine HydrochlorideSAFEWAY INC.ANDACurrent
41163-353RanitidineRanitidine HydrochlorideSupervalu Inc.ANDACurrent
46122-223RanitidineRanitidineAmerisource BergenANDACurrent
49035-353RanitidineRanitidine HydrochlorideWal-Mart Stores, IncANDACurrent
49348-473RanitidineRanitidineSunmarkANDACurrent
49781-026RanitidineRanitidineCardinal HealthANDACurrent
50804-352Acid ReducerRanitidineGood SenseANDACurrent
51660-352Acid ReducerRanitidine HydrochlorideOhm Laboratories Inc.ANDACurrent
55315-352RanitidineRanitidineFred's Inc.ANDACurrent
55319-352Regular Strength Acid ReducerRanitidineFamily DollarANDACurrent
57910-405RanitidineRanitidineShasun Pharmaceuticals LimitedANDACurrent
59556-945Acid Reducerranitidine hydrochlorideStrides Pharma IncANDACurrent
59779-356RanitidineRanitidineCVS Pharmacy, IncANDACurrent
61715-090Acid ReducerRanitidinePreferred Plus (Kinray)ANDACurrent
61715-090Acid ReducerRanitidinePreferred Plus (Kinray)ANDACurrent
62011-0225RanitidineRanitidineHealth MartANDACurrent
63868-711RanitidineRanitidine HydrochlorideChain Drug Marketing Association Inc.ANDACurrent
63941-352RanitidineRanitidine HydrochlorideValu Merchandisers CompanyANDACurrent
67091-244Acid ReducerRanitidine HydrochlorideWinCo Foods, LLCANDACurrent
68016-352Ranitidine - Acid ReducerRanitidine HydrochlorideChain Drug Consortium, LLC.ANDACurrent