Home Applications 021454 Application 021454
Type NDA
Sponsor AUXILIUM PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TESTIM TESTOSTERONE GEL;TRANSDERMAL 50MG/5GM PACKET Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021454-001 TESTIM TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021454-001 AB2
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N021454-001 AB2 1 a50c72e98297…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Testim TESTOSTERONE Endo USA, Inc. 9f2aae1f-898d-4955-be31-678e0cf85395 2025-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021454 application number: NDA021454 ndc (product): 66887-001
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0254-1012 Testosterone testosterone Par Pharmaceutical, Inc. NDA AUTHORIZED GENERIC Current 0254-1012 Testosterone testosterone Par Pharmaceutical, Inc. NDA AUTHORIZED GENERIC Current 0254-1012 Testosterone testosterone Par Pharmaceutical, Inc. NDA AUTHORIZED GENERIC Current 66887-001 Testim testosterone Endo Pharmaceuticals Inc. NDA Current 66887-001 Testim testosterone Endo Pharmaceuticals, Inc. NDA Current 66887-001 Testim testosterone Endo Pharmaceuticals, Inc. NDA Current 66887-001 Testim testosterone Endo Pharmaceuticals Inc. NDA Current