FDA.reportPublic FDA data

Application 021543

Type
NDA
Sponsor
AUXILIUM PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STRIANTTESTOSTERONETABLET, EXTENDED RELEASE;BUCCAL30MGYesNo

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
N021543-001STRIANTTESTOSTERONE30MGTABLET, EXTENDED RELEASE / BUCCALRLD2003-06-19

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 22:54:322026-06N021543-001STRIANT30MGTABLET, EXTENDED RELEASE / BUCCALRLD2003-06-19a50c72e98297…

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TestosteroneTESTOSTERONEEncube Ethicals, Inc.ca5d4865-356b-45e7-b603-fe299e450abc2026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TESTOSTERONETESTOSTERONEEncube Ethicals, Inc.44a04f66-fd2a-45c7-934e-8f14c023ce142026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONENorthstar Rx LLC65981b8a-d5cc-1964-7eac-a07f032c25712026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEXiromed, LLC28e8d504-5073-1d78-f351-bcb7c5188ee62026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONELupin Pharmaceuticals, Inc.29c8846f-121c-4958-9e03-3bd271c215582026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONELupin Pharmaceuticals, Inc.61387416-510d-40c5-9e2d-24bfb7f56d082026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEBryant Ranch Prepackc6c0a39e-0e75-4356-a052-c26c30c76b262025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEActavis Pharma, Inc.5834d34f-839d-412c-b74c-da1dad2cfa882025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEActavis Pharma, Inc.e18b4495-c5a3-4a7f-9636-1793207843812025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEBryant Ranch Prepack6c7d2dec-6492-4d53-b110-61ffeae9ee612025-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
testosteroneTESTOSTERONENorthstar Rx LLC2d55b825-8eab-4091-bdf2-9c52d111b8eb2025-08-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
testosteroneTESTOSTERONEPadagis Israel Pharmaceuticals Ltd54fcdcb9-fb0e-4164-9e51-f2a5feae32172025-08-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEStrides Pharma Science Limitedee54c393-bcfe-4a52-b7b3-1da8750f35d92025-08-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEActavis Pharma, Inc.4f3c2c0a-7dab-4b50-9cae-869c3c2a84982025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
testosteroneTESTOSTERONEBryant Ranch Prepack9e10a37a-9c40-456b-a362-2fa8eae31e842025-07-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
Natesto nasal gelTESTOSTERONEAcerus Pharmaceuticals Corporationdea6bed1-eaca-11e3-ac10-0800200c9a662025-07-22Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestopelTESTOSTERONEEndo USA, Inc.03b9c0b1-5884-11e4-8ed6-0800200c9a662025-07-17Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TestimTESTOSTERONEEndo USA, Inc.9f2aae1f-898d-4955-be31-678e0cf853952025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
VogelxoTESTOSTERONEUpsher-Smith Laboratories, LLC2dd150f6-cdfd-4d51-8888-12b288f262622025-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE
TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals Inc.e39289aa-681c-47ec-9461-52e7f17e5d712025-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52244-030StrianttestosteroneEndo Pharmaceuticals, Inc.NDACurrent
52244-030StrianttestosteroneEndo Pharmaceuticals, Inc.NDACurrent
52244-030StrianttestosteroneEndo Pharmaceuticals Inc.NDACurrent
55056-3060StrianttestosteroneColumbia Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45753SUPPL2016-11-01
45675SUPPL2016-10-27
37193SUPPL2015-05-13
28077SUPPL2015-05-13
28076SUPPL2014-06-23
15736SUPPL2014-06-23
37192SUPPL2014-03-25
5689SUPPL2014-03-25
28075SUPPL2004-11-08
15735SUPPL2004-11-08
42206ORIG2004-10-26
5688SUPPL2003-11-28
15734ORIG2003-06-22
5687ORIG2003-06-22