FDA.reportPublic FDA data

Application 090842

Type
ANDA
Sponsor
INVAGEN PHARMS

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
A090842-001RALOXIFENE HYDROCHLORIDERALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090842-001AB

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 22:54:322026-06A090842-001RALOXIFENE HYDROCHLORIDE60MGTABLET / ORALAB2014-09-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090842-001AB1a50c72e98297…

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 HydrochlorideRALOXIFENEAmerican Health Packagingf5c25553-1546-451d-8069-c0f484c477412024-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
ndc (product): 60687-266
Raloxifene HydrochlorideRALOXIFENEAphena Pharma Solutions - Tennessee, LLC53a2db10-4af8-4032-b598-b7c7a09698012021-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
ndc (product): 71610-524
Raloxifene HydrochlorideRALOXIFENE HYDROCHLORIDEExelan Pharmaceuticals, Inc.2b94ecf5-d870-4132-b455-d5ee5c9dce562020-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
ndc (product): 76282-256
Raloxifene HydrochlorideRALOXIFENECipla USA Inc.8fef5bfd-a786-4442-b09b-f3b81812cdac2020-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090842
application number: ANDA090842
ndc (product): 69097-825

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-5295Raloxifene HydrochlorideRaloxifene HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
31722-256Raloxifene HydrochlorideRaloxifene HydrochlorideCamber Pharmaceuticals IncANDACurrent
50090-5458Raloxifene HydrochlorideRaloxifeneA-S Medication SolutionsANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
60687-266Raloxifene HydrochlorideRaloxifeneAmerican Health PackagingANDACurrent
63629-7708Raloxifene HydrochlorideRaloxifeneBryant Ranch PrepackANDACurrent
63629-7708Raloxifene HydrochlorideRaloxifeneBryant Ranch PrepackANDACurrent
69097-825Raloxifene HydrochlorideRaloxifeneCipla USA Inc.ANDACurrent
69097-825Raloxifene HydrochlorideRaloxifeneCipla USA Inc.ANDACurrent
69097-825Raloxifene HydrochlorideRaloxifeneCipla USA Inc.ANDACurrent
70518-3046Raloxifene HydrochlorideRaloxifeneREMEDYREPACK INC.ANDACurrent
71335-1663Raloxifene HydrochlorideRaloxifeneBryant Ranch PrepackANDACurrent
71335-1663Raloxifene HydrochlorideRaloxifeneBryant Ranch PrepackANDACurrent
71610-524Raloxifene HydrochlorideRaloxifeneAphena Pharma Solutions - Tennessee, LLCANDACurrent
76282-256Raloxifene HydrochlorideRaloxifene HydrochlorideExelan Pharmaceuticals, Inc.ANDACurrent
76282-256Raloxifene HydrochlorideRaloxifene HydrochlorideExelan Pharmaceuticals, Inc.ANDACurrent
76282-256Raloxifene HydrochlorideRaloxifene HydrochlorideExelan Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54299ORIG2018-05-22