FDA.reportPublic FDA data

Application 078193

Type
ANDA
Sponsor
TEVA PHARMS USA

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
A078193-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078193-001AB

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 22:54:322026-06A078193-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-03-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078193-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEBryant Ranch Prepack3568ed3c-6afd-4872-a861-93a7873bec9c2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078193
application number: ANDA078193
ndc (product): 71335-1715
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.e6be5b1d-757d-4bab-ad6a-c421960a104d2021-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078193
application number: ANDA078193
ndc (product): 0093-7290

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7290Raloxifene HydrochlorideRaloxifene HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-726Raloxifene HydrochlorideRaloxifene HydrochlorideAvKARE, Inc.ANDACurrent
42291-726Raloxifene HydrochlorideRaloxifene HydrochlorideAvKAREANDACurrent
68071-2412Raloxifene HydrochlorideRaloxifene HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2994Raloxifene HydrochlorideRaloxifene HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1715Raloxifene HydrochlorideRaloxifene HydrochlorideBryant Ranch PrepackANDACurrent
71335-1715Raloxifene HydrochlorideRaloxifene HydrochlorideBryant Ranch PrepackANDACurrent
71610-504Raloxifene HydrochlorideRaloxifene HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52769ORIG2018-02-28
9129ORIG2014-03-06