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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TestosteroneTESTOSTERONEAmneal Pharmaceuticals NY LLCf9888b14-67f4-4c87-8f7b-d51baef9891b2025-07-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEUpsher-Smith Laboratories, LLCa887020f-b41f-49fe-8379-f01147b2a7962025-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
testosteroneTESTOSTERONEPadagis Israel Pharmaceuticals Ltdc0c56607-e995-4bed-9c62-e33a722b38b52025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: testosterone
generic name: TESTOSTERONE
testosteroneTESTOSTERONEBryant Ranch Prepack78384754-5883-46b1-84e7-c063b4b4be822025-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEUpsher-Smith Laboratories, LLC10dab294-6a43-4bb3-9d91-2d200c624ffb2025-06-10Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONECipla USA Inc.6a46b5de-5d95-4570-91a6-3e4278028c592025-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEActavis Pharma, Inc.7227ab2f-c8ef-4bab-92ab-3092182abcc92025-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEZoe Processing0bb2581c-5a65-469b-8f9a-954ac9cc90fb2025-02-03WarningsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEPrasco Laboratories68b2375d-0365-4797-bc3d-63531c9f42fd2024-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
testosteroneTESTOSTERONEBryant Ranch Prepack5be74193-de73-436d-a9a1-35a857bc8e0c2024-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEPrasco Laboratories0d84e5a6-11e9-4940-8991-21c611c4c32f2024-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
testosteroneTESTOSTERONEBryant Ranch Prepackd22a072f-529b-4878-90fc-4365d9dc67e62024-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEDeseret Biologicals, Inc.c16ddade-d47a-4296-8926-d19d9f671aa32024-02-27WarningsName fallback
brand name: Testosterone
generic name: TESTOSTERONE
TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals Inc.21705fce-bc6c-41f6-aa92-fa6fc1c22fb62023-12-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TESTOSTERONE
generic name: TESTOSTERONE
testosteroneTESTOSTERONEBryant Ranch Prepack86254445-efd1-46d9-8236-3a0d98316f282023-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: testosterone
generic name: TESTOSTERONE
TestosteroneTESTOSTERONEDr. Reddy's Laboratories, Inc.ccadef00-3d5f-f926-e0fb-8dabe859f2712019-05-21Boxed 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.