Home NDC 72763-201-10 Tavaborole
Product NDC 72763-201
Requested package NDC 72763-201-10
11-digit product format 727630201
Labeler code 72763
Product ID 72763-201_e6c4d2f8-070c-4a81-9242-f2edca9b846f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tavaborole
Dosage form LIQUID
Route TOPICAL
Labeler Estreno Pharma, LLC
Application ANDA211963
Marketing category ANDA
Marketing start 2021-02-04
Marketing end 0000-00-00
Substance TAVABOROLE
Active strength 44 mg/mL
Pharmacologic classes Oxaborole Antifungal [EPC],Protein Synthesis Inhibitors [MoA],Boron Compounds [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A211963-001 TAVABOROLE TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211963-001 AB
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 2026-08-18 06:07:40 2026-07 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL 2021-02-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL 2021-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL 2021-02-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211963-001 TAVABOROLE 5.0% SOLUTION / TOPICAL AB 2021-02-03 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211963-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-03 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A211963-001 PC 2021-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211963-001 PC 2021-04-17 87673890dc5c…
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72763-201-10 72763020110 1 BOTTLE in 1 CARTON (72763-201-10) > 10 mL in 1 BOTTLE 1 bottle 2021-02-04 0000-00-00 No No Current