Home Applications 213584 Application 213584
Type ANDA
Sponsor TARO PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE UNKNOWN UNKNOWN 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 A213584-001 OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL AB 2021-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213584-001 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 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL AB 2021-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL 2021-10-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213584-001 OXYMETAZOLINE HYDROCHLORIDE 1% CREAM / TOPICAL AB 2021-10-04 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A213584-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213584-001 AB 1 a50c72e98297…
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51672-1405 Oxymetazoline Hydrochloride Oxymetazoline Hydrochloride Taro Pharmaceuticals U.S.A., Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 67408 ORIG 2021-05-05