Application 020489
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANDRODERM | TESTOSTERONE | FILM, EXTENDED RELEASE;TRANSDERMAL | 2.5MG/24HR | No | No |
| 002 | ANDRODERM | TESTOSTERONE | FILM, EXTENDED RELEASE;TRANSDERMAL | 5MG/24HR | No | No |
| 003 | ANDRODERM | TESTOSTERONE | FILM, EXTENDED RELEASE;TRANSDERMAL | 2MG/24HR | Yes | Yes |
| 004 | ANDRODERM | TESTOSTERONE | FILM, EXTENDED RELEASE;TRANSDERMAL | 4MG/24HR | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020489-001 | ANDRODERM | TESTOSTERONE | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | ||
| N020489-002 | ANDRODERM | TESTOSTERONE | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | ||
| N020489-003 | ANDRODERM | TESTOSTERONE | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | |
| N020489-004 | ANDRODERM | TESTOSTERONE | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 |
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 | 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 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020489-001 | ANDRODERM | 2.5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1995-09-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020489-002 | ANDRODERM | 5MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 1997-05-02 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020489-003 | ANDRODERM | 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020489-004 | ANDRODERM | 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2011-10-20 | d8e5a09893c0… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Testosterone | TESTOSTERONE | Encube Ethicals, Inc. | ca5d4865-356b-45e7-b603-fe299e450abc | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| TESTOSTERONE | TESTOSTERONE | Encube Ethicals, Inc. | 44a04f66-fd2a-45c7-934e-8f14c023ce14 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Northstar Rx LLC | 65981b8a-d5cc-1964-7eac-a07f032c2571 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Xiromed, LLC | 28e8d504-5073-1d78-f351-bcb7c5188ee6 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Lupin Pharmaceuticals, Inc. | 29c8846f-121c-4958-9e03-3bd271c21558 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Lupin Pharmaceuticals, Inc. | 61387416-510d-40c5-9e2d-24bfb7f56d08 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Bryant Ranch Prepack | c6c0a39e-0e75-4356-a052-c26c30c76b26 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | 5834d34f-839d-412c-b74c-da1dad2cfa88 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | e18b4495-c5a3-4a7f-9636-179320784381 | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Bryant Ranch Prepack | 6c7d2dec-6492-4d53-b110-61ffeae9ee61 | 2025-09-03 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| testosterone | TESTOSTERONE | Northstar Rx LLC | 2d55b825-8eab-4091-bdf2-9c52d111b8eb | 2025-08-31 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| testosterone | TESTOSTERONE | Padagis Israel Pharmaceuticals Ltd | 54fcdcb9-fb0e-4164-9e51-f2a5feae3217 | 2025-08-31 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Strides Pharma Science Limited | ee54c393-bcfe-4a52-b7b3-1da8750f35d9 | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | 4f3c2c0a-7dab-4b50-9cae-869c3c2a8498 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| testosterone | TESTOSTERONE | Bryant Ranch Prepack | 9e10a37a-9c40-456b-a362-2fa8eae31e84 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Natesto nasal gel | TESTOSTERONE | Acerus Pharmaceuticals Corporation | dea6bed1-eaca-11e3-ac10-0800200c9a66 | 2025-07-22 | Warnings, Adverse reactions | TESTOSTERONE |
| Testopel | TESTOSTERONE | Endo USA, Inc. | 03b9c0b1-5884-11e4-8ed6-0800200c9a66 | 2025-07-17 | Warnings, Adverse reactions | TESTOSTERONE |
| Testim | TESTOSTERONE | Endo USA, Inc. | 9f2aae1f-898d-4955-be31-678e0cf85395 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Vogelxo | TESTOSTERONE | Upsher-Smith Laboratories, LLC | 2dd150f6-cdfd-4d51-8888-12b288f26262 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| TESTOSTERONE | TESTOSTERONE | Alembic Pharmaceuticals Inc. | e39289aa-681c-47ec-9461-52e7f17e5d71 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-5990 | Androderm | Testosterone | Allergan, Inc. | NDA | Current |
| 0023-5990 | Androderm | Testosterone | Allergan, Inc. | NDA | Current |
| 0023-5990 | Androderm | Testosterone | Allergan, Inc. | NDA | Current |
| 0023-5992 | Androderm | Testosterone | Allergan, Inc. | NDA | Current |
| 0023-5992 | Androderm | Testosterone | Allergan, Inc. | NDA | Current |
| 0023-5992 | Androderm | Testosterone | Allergan, Inc. | NDA | Current |
| 52544-076 | Androderm | Testosterone | Actavis Pharma, Inc. | NDA | Current |
| 52544-077 | Androderm | Testosterone | Actavis Pharma, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62941 | SUPPL | 2020-05-13 |
| 62916 | SUPPL | 2020-05-12 |
| 60057 | SUPPL | 2019-09-20 |
| 60053 | SUPPL | 2019-09-19 |
| 45752 | SUPPL | 2016-11-01 |
| 45671 | SUPPL | 2016-10-27 |
| 25041 | SUPPL | 2015-05-13 |
| 12632 | SUPPL | 2015-05-13 |
| 34706 | SUPPL | 2014-06-23 |
| 2596 | SUPPL | 2014-06-23 |
| 25040 | SUPPL | 2012-05-02 |
| 34705 | SUPPL | 2012-05-01 |
| 25039 | SUPPL | 2011-10-25 |
| 12631 | SUPPL | 2011-10-25 |
| 20679 | SUPPL | 2007-07-06 |
| 34704 | SUPPL | 2006-05-22 |
| 2595 | SUPPL | 2006-05-22 |
| 25038 | SUPPL | 2002-08-09 |
| 25037 | SUPPL | 2002-01-15 |
| 41394 | SUPPL | 1997-05-02 |