Home Applications 205309 Application 205309
Type ANDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TIMOLOL TIMOLOL SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE No No 002 TIMOLOL TIMOLOL SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205309-001 TIMOLOL TIMOLOL 0.25% SOLUTION/DROPS / OPHTHALMIC 2016-09-30 A205309-002 TIMOLOL TIMOLOL 0.5% SOLUTION/DROPS / OPHTHALMIC 2016-09-30
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 2 of 3 · 88 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 2019-12-13 00:20 UTC 2019-12 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC 2016-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205309-001 TIMOLOL EQ 0.25% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205309-002 TIMOLOL EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT 2016-09-30 3a93d1ddd44b…
Observed Orange Book normalized TE 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 17478-365 Timolol Maleate Timolol Akorn, Inc. ANDA Current 17478-365 Timolol Maleate Timolol Akorn ANDA Current 17478-365 Timolol Maleate Timolol Akorn, Inc. ANDA Current 17478-366 Timolol Maleate Timolol Akorn, Inc. ANDA Current 17478-366 Timolol Maleate Timolol Akorn ANDA Current 17478-366 Timolol Maleate Timolol Akorn, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 45589 ORIG 2016-10-05