FDA.reportPublic FDA data

Application 203822

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RISEDRONATE SODIUMRISEDRONATE SODIUMTABLET, DELAYED RELEASE;ORAL35MGNoNo

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
A203822-001RISEDRONATE SODIUMRISEDRONATE SODIUM35MGTABLET, DELAYED RELEASE / ORAL2018-09-11

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 UTC2022-10A203822-001RISEDRONATE SODIUM35MGTABLET, DELAYED RELEASE / ORAL2018-09-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203822-001RISEDRONATE SODIUM35MGTABLET, DELAYED RELEASE / ORAL2018-09-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203822-001RISEDRONATE SODIUM35MGTABLET, DELAYED RELEASE / ORAL2018-09-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203822-001RISEDRONATE SODIUM35MGTABLET, DELAYED RELEASE / ORAL2018-09-11a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Risedronate SodiumRISEDRONATE SODIUMTeva Pharmaceuticals USA, Inc.dddcd321-4d2e-4643-bf3c-7b752b33ba392026-03-30Warnings, Adverse reactionsName fallback
brand name: Risedronate Sodium
generic name: RISEDRONATE SODIUM
Risedronate SodiumRISEDRONATE SODIUMApotex Corp.b90f2e5b-10b8-29a7-0360-31bd0dae0ec22026-03-02Warnings, Adverse reactionsName fallback
brand name: Risedronate Sodium
generic name: RISEDRONATE SODIUM
Risedronate SodiumRISEDRONATE SODIUMMacleods Pharmaceuticals Limited62aff8d6-a2f7-4c7e-a102-c70105ac37922026-03-01Warnings, Adverse reactionsName fallback
brand name: Risedronate Sodium
generic name: RISEDRONATE SODIUM
risedronate sodiumRISEDRONATE SODIUMSun Pharmaceutical Industries, Inc.e0b5f0ed-ff40-4f0d-bb86-81a7ace9f3392026-02-17Warnings, Adverse reactionsName fallback
brand name: risedronate sodium
generic name: RISEDRONATE SODIUM
Risedronate SodiumRISEDRONATE SODIUMMylan Pharmaceuticals, Inc.f715718a-407d-4e2a-9834-74a8f1361d032026-02-12Warnings, Adverse reactionsName fallback
brand name: Risedronate Sodium
generic name: RISEDRONATE SODIUM
Risedronate SodiumRISEDRONATE SODIUMAurobindo Pharma Limited89896dfe-f69d-4cb3-bb71-7a7c611071fa2026-02-11Warnings, Adverse reactionsName fallback
brand name: Risedronate Sodium
generic name: RISEDRONATE SODIUM
Risedronate SodiumRISEDRONATE SODIUMAurobindo Pharma Limiteda42a35e6-3e08-4b4f-ae56-47d4aec2322a2026-02-10Warnings, Adverse reactionsName fallback
brand name: Risedronate Sodium
generic name: RISEDRONATE SODIUM
ActonelRISEDRONATE SODIUMAllergan, Inc.24ed00e0-25e2-49a8-97fc-66c1b417dc0b2026-02-04Warnings, Adverse reactionsName fallback
generic name: RISEDRONATE SODIUM
AtelviaRISEDRONATE SODIUMAllergan, Inc.c8b9ab88-1a26-46c3-80ec-4eaa452020212026-02-03Warnings, Adverse reactionsName fallback
generic name: RISEDRONATE SODIUM
Risedronate SodiumRISEDRONATE SODIUMMylan Pharmaceuticals, Inc.c89430be-15f1-4b8b-ab7e-738de716ee7d2026-02-03Warnings, Adverse reactionsName fallback
brand name: Risedronate Sodium
generic name: RISEDRONATE SODIUM
Risedronate SodiumRISEDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical CO., Ltdd60a56cb-ef49-4447-9043-7b6879a20d752025-12-16Warnings, Adverse reactionsName fallback
brand name: Risedronate Sodium
generic name: RISEDRONATE SODIUM
Risedronate SodiumRISEDRONATE SODIUMProficient Rx LP81702f21-3117-49ce-8e9b-2aa2648ba7c32022-11-01Warnings, Adverse reactionsName fallback
brand name: Risedronate Sodium
generic name: RISEDRONATE SODIUM
RISEDRONATE SODIUMRISEDRONATE SODIUMSun Pharmaceutical Industires Inc.1d9e520b-2fa6-4603-b397-f0fc24fae7752020-09-09Warnings, Adverse reactionsName fallback
brand name: RISEDRONATE SODIUM
generic name: RISEDRONATE SODIUM

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-075Risedronate SodiumRisedronate SodiumZydus Pharmaceuticals USA Inc.ANDACurrent
68382-075Risedronate SodiumRisedronate SodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-075Risedronate SodiumRisedronate SodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-075Risedronate SodiumRisedronate SodiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1436Risedronate SodiumRisedronate SodiumCadila Healthcare LimitedANDACurrent
70771-1436Risedronate SodiumRisedronate SodiumCadila Healthcare LimitedANDACurrent
70771-1436Risedronate SodiumRisedronate SodiumCadila Healthcare LimitedANDACurrent
70771-1436Risedronate SodiumRisedronate SodiumZydus Lifesciences LimitedANDACurrent