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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 241 observed states.
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 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