Home Applications 205488 Application 205488
Type NDA
Sponsor ACERUS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NATESTO TESTOSTERONE GEL, METERED;NASAL 5.5MG/0.122GM ACTUATION No No
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 N205488-001 NATESTO TESTOSTERONE 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205488-001 11090312 2034-03-17 U-1616 2021-09-10 N205488-001 11744838 2034-03-17 U-4366 2026-01-07 N205488-001 11744838 2034-03-17 U-4367 2026-01-07
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 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 5 · 180 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205488-001 11744838 2034-03-17 U-4366 2026-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205488-001 11744838 2034-03-17 U-4367 2026-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205488-001 11744838 2034-03-17 U-4366 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205488-001 11744838 2034-03-17 U-4367 2026-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 79d66fd596c7…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42667-5511 Natesto testosterone Acerus Pharmaceuticals Corporation NDA Current 42667-5511 Natesto testosterone Acerus Pharmaceuticals Corporation NDA Current 42667-5511 Natesto testosterone Acerus Pharmaceuticals Corporation NDA Current 42667-5511 Natesto testosterone Acerus Pharmaceuticals Corporation NDA Current 69654-239 Natesto testosterone Aytu BioScience, Inc. NDA Current 69654-239 Natesto testosterone Aytu BioScience, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82863 SUPPL 2025-07-15 82849 SUPPL 2025-07-14 45751 SUPPL 2016-11-01 45682 SUPPL 2016-10-27 32680 SUPPL 2015-05-13 19651 SUPPL 2015-05-13 44920 ORIG 2015-01-29 22992 ORIG 2015-01-29 10453 ORIG 2014-06-02 40472 ORIG 2014-05-30