FDA.reportPublic FDA data

Application 022504

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AXIRONTESTOSTERONESOLUTION, METERED;TRANSDERMAL30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N022504-001AXIRONTESTOSTERONE30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION, METERED / TRANSDERMALRLD2010-11-23

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022504-00189935202026-06-02U-13902015-04-09
N022504-00191801942026-06-02U-13902015-12-03
N022504-00184193072027-02-26U-13862013-04-30
N022504-00188078612027-02-26U-1563Drug product2014-09-10
N022504-00192895862027-02-26U-13902016-04-19
N022504-00184359442027-09-27U-1390

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 22:54:322026-06N022504-001AXIRON30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION, METERED / TRANSDERMALRLD2010-11-23a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022504-00189935202026-06-02U-13902015-04-09a50c72e98297…
2026-08-01 22:54:322026-06N022504-00191801942026-06-02U-13902015-12-03a50c72e98297…
2026-08-01 22:54:322026-06N022504-00184193072027-02-26U-13862013-04-30a50c72e98297…
2026-08-01 22:54:322026-06N022504-00188078612027-02-26U-1563Drug product2014-09-10a50c72e98297…
2026-08-01 22:54:322026-06N022504-00192895862027-02-26U-13902016-04-19a50c72e98297…
2026-08-01 22:54:322026-06N022504-00184359442027-09-27U-1390a50c72e98297…

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48988SUPPL2017-07-14
48982SUPPL2017-07-14
48981SUPPL2017-07-14
47127SUPPL2017-02-07
47100SUPPL2017-02-06
46988SUPPL2017-01-27
45744SUPPL2016-11-01
45678SUPPL2016-10-27
29792SUPPL2015-05-13
17653SUPPL2015-05-13
42542SUPPL2014-07-07
38770SUPPL2014-06-23
7465SUPPL2014-06-23
29791SUPPL2011-12-28
17652SUPPL2011-12-23
44763ORIG2011-09-16
22038ORIG2011-09-16
44506ORIG2011-04-04
29790SUPPL2011-04-04
17651SUPPL2011-04-01
29789ORIG2010-11-29
38769ORIG2010-11-23