FDA.reportPublic FDA data

Application 204310

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDETABLET;ORAL60MGNoNo

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

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
A204310-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2015-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204310-001AB

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 22:54:322026-06A204310-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2015-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204310-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEA-S Medication Solutions804e873e-f48b-4c25-ad7b-41d44f61bdde2025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204310
application number: ANDA204310
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepack5a22ae27-1c55-487b-8e93-8ef1cec870652024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204310
application number: ANDA204310
ndc (product): 71335-2059
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDENorthStar Rx LLC0f7d1f81-374f-4ad5-aea0-2f97abbe1dbf2024-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204310
application number: ANDA204310
ndc (product): 16714-213
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEAurobindo Pharma Limitede8b6cbe0-c1f4-4678-b852-f629a7f6a1b52024-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204310
application number: ANDA204310
ndc (product): 65862-709

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-213Raloxifene HydrochlorideRaloxifene HydrochlorideNorthStar Rx LLCANDACurrent
43353-253Raloxifene HydrochlorideRaloxifene HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
52343-137Raloxifene HydrochlorideRaloxifene HydrochlorideACETRIS HEALTH, LLCANDACurrent
52343-137Raloxifene HydrochlorideRaloxifene HydrochlorideLUCID PHARMA LLCANDACurrent
65862-709Raloxifene HydrochlorideRaloxifene HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-709Raloxifene HydrochlorideRaloxifene HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-709Raloxifene HydrochlorideRaloxifene HydrochlorideAurobindo Pharma LimitedANDACurrent
66993-661Raloxifene HydrochlorideRaloxifene HydrochloridePrasco LaboratoriesANDACurrent
66993-661Raloxifene HydrochlorideRaloxifene HydrochloridePrasco LaboratoriesANDACurrent
66993-661Raloxifene HydrochlorideRaloxifene HydrochloridePrasco LaboratoriesANDACurrent
71335-2059Raloxifene HydrochlorideRaloxifene HydrochlorideBryant Ranch PrepackANDACurrent