FDA.reportPublic FDA data

Application 207337

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONETESTOSTERONESOLUTION, METERED;TRANSDERMAL30MG/1.5ML ACTUATIONNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
brand name: Testosterone
generic name: TESTOSTERONE
TESTOSTERONETESTOSTERONEEncube Ethicals, Inc.44a04f66-fd2a-45c7-934e-8f14c023ce142026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TESTOSTERONE
generic name: TESTOSTERONE
TestosteroneTESTOSTERONENorthstar Rx LLC65981b8a-d5cc-1964-7eac-a07f032c25712026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEXiromed, LLC28e8d504-5073-1d78-f351-bcb7c5188ee62026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONELupin Pharmaceuticals, Inc.29c8846f-121c-4958-9e03-3bd271c215582026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONELupin Pharmaceuticals, Inc.61387416-510d-40c5-9e2d-24bfb7f56d082026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEBryant Ranch Prepackc6c0a39e-0e75-4356-a052-c26c30c76b262025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEActavis Pharma, Inc.5834d34f-839d-412c-b74c-da1dad2cfa882025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEActavis Pharma, Inc.e18b4495-c5a3-4a7f-9636-1793207843812025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEBryant Ranch Prepack6c7d2dec-6492-4d53-b110-61ffeae9ee612025-09-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
testosteroneTESTOSTERONENorthstar Rx LLC2d55b825-8eab-4091-bdf2-9c52d111b8eb2025-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: testosterone
generic name: TESTOSTERONE
testosteroneTESTOSTERONEPadagis Israel Pharmaceuticals Ltd54fcdcb9-fb0e-4164-9e51-f2a5feae32172025-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEStrides Pharma Science Limitedee54c393-bcfe-4a52-b7b3-1da8750f35d92025-08-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEActavis Pharma, Inc.4f3c2c0a-7dab-4b50-9cae-869c3c2a84982025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
testosteroneTESTOSTERONEBryant Ranch Prepack9e10a37a-9c40-456b-a362-2fa8eae31e842025-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: testosterone
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
brand name: TESTOSTERONE
generic name: TESTOSTERONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.