FDA.reportPublic FDA data

Application 075167

Type
ANDA
Sponsor
APOTEX INC

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
A075167-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-05-04

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 UTC2022-09A075167-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-05-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075167-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-05-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075167-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-05-04a50c72e98297…

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1029Wal-ZanWal-ZanWalgreens CompanyANDACurrent
0363-1029Wal-ZanWal-ZanWalgreens CompanyANDACurrent
57896-765ACID REDUCER 75Ranitidine HydrochlorideGERI-CARE PHARMACEUTICAL CORPANDACurrent
60505-0160RanitidineRanitidine hydrochlorideApotex Corp.ANDACurrent
60505-0160RanitidineRanitidine hydrochlorideApotex Corp.ANDACurrent
60505-0160RanitidineRanitidine hydrochlorideApotex Corp.ANDACurrent
60505-2881RanitidineRanitidine hydrochlorideApotex Corp.ANDACurrent
60505-2881RanitidineRanitidine hydrochlorideApotex Corp.ANDACurrent
60505-2881RanitidineRanitidine hydrochlorideApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30779ORIG2000-05-04