Home Applications 208088 Application 208088
Type NDA
Sponsor LIPOCINE INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TESTOSTERONE UNDECANOATE TESTOSTERONE UNDECANOATE UNKNOWN UNKNOWN Yes No
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 N208088-001 TLANDO TESTOSTERONE UNDECANOATE 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208088-001 11304960 2029-01-08 U-1500 Drug product 2022-04-27 N208088-001 8778922 2029-01-08 U-1500 Drug product 2022-04-27 N208088-001 8865695 2029-01-08 U-1500 2022-04-27 N208088-001 10226473 2030-11-30 U-1500 2022-04-27 N208088-001 10716794 2030-11-30 U-1500 2022-04-27 N208088-001 11311555 2030-11-30 U-1500 2022-05-26 N208088-001 11364249 2030-11-30 U-1500 2022-07-19 N208088-001 11433083 2030-11-30 U-1500 2022-10-06 N208088-001 9943527 2030-11-30 U-1500 2022-04-27 N208088-001 9949985 2030-11-30 U-1500 2022-04-27 N208088-001 11559530 2037-11-28 U-1500 2023-02-14 N208088-001 12310978 2039-02-21 U-4194 2025-06-11 N208088-001 12011503 2040-10-16 U-3964 Drug product 2024-07-17 N208088-001 12011503 2040-10-16 U-3965 Drug product 2024-07-17 N208088-001 11464735 2041-04-28 U-1500 Drug product 2022-11-10
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 2026-02-19 14:30 UTC 2026-02 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 360 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208088-001 11304960 2029-01-08 U-1500 Drug product 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 8778922 2029-01-08 U-1500 Drug product 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 8865695 2029-01-08 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 10226473 2030-11-30 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 10716794 2030-11-30 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11311555 2030-11-30 U-1500 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11364249 2030-11-30 U-1500 2022-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11433083 2030-11-30 U-1500 2022-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 9943527 2030-11-30 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 9949985 2030-11-30 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11559530 2037-11-28 U-1500 2023-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 12310978 2039-02-21 U-4194 2025-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 12011503 2040-10-16 U-3964 Drug product 2024-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 12011503 2040-10-16 U-3965 Drug product 2024-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11464735 2041-04-28 U-1500 Drug product 2022-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11304960 2029-01-08 U-1500 Drug product 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 8778922 2029-01-08 U-1500 Drug product 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 8865695 2029-01-08 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 10226473 2030-11-30 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 10716794 2030-11-30 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11311555 2030-11-30 U-1500 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11364249 2030-11-30 U-1500 2022-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11433083 2030-11-30 U-1500 2022-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 9943527 2030-11-30 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 9949985 2030-11-30 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11559530 2037-11-28 U-1500 2023-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 12310978 2039-02-21 U-4194 2025-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 12011503 2040-10-16 U-3964 Drug product 2024-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 12011503 2040-10-16 U-3965 Drug product 2024-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11464735 2041-04-28 U-1500 Drug product 2022-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208088-001 11304960 2029-01-08 U-1500 Drug product 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 8778922 2029-01-08 U-1500 Drug product 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 8865695 2029-01-08 U-1500 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 10226473 2030-11-30 U-1500 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 10716794 2030-11-30 U-1500 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 11311555 2030-11-30 U-1500 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 11364249 2030-11-30 U-1500 2022-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 11433083 2030-11-30 U-1500 2022-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 9943527 2030-11-30 U-1500 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 9949985 2030-11-30 U-1500 2022-04-27 6a471c1ec25d…
Observed Orange Book exclusivity history# 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 Tlando TESTOSTERONE UNDECANOATE Verity Pharmaceuticals Inc. 4b0b92e9-6d3c-a0e5-e1c7-342999f72580 2026-02-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 208088 application number: NDA208088
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54436-112 Tlando testosterone undecanoate Antares Pharma, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82864 SUPPL 2025-07-15 82851 SUPPL 2025-07-14 82850 SUPPL 2025-07-14 73587 ORIG 2023-02-22 70638 ORIG 2022-03-29 70636 ORIG 2022-03-29 65541 ORIG 2020-12-09