Home Applications 075915 Application 075915
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TIOCONAZOLE TIOCONAZOLE OINTMENT;VAGINAL 6.5% No 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 A075915-001 TIOCONAZOLE TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075915-001 TIOCONAZOLE 6.5% OINTMENT / VAGINAL 2001-11-21 cb3db0bc1861…
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 · 19 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 41 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0426 good sense tioconazole 1 Tioconazole L. Perrigo Company ANDA Current 0113-7426 basic care tioconazole 1 Tioconazole L. Perrigo Company ANDA Current 0113-7426 basic care tioconazole 1 Tioconazole L. Perrigo Company ANDA Current 0113-7426 basic care tioconazole 1 Tioconazole L. Perrigo Company ANDA Current 0363-0426 Tioconazole 1 Tioconazole Walgreen Company ANDA Current 0363-0426 Tioconazole 1 Tioconazole Walgreen Company ANDA Current 0363-0426 Tioconazole 1 Tioconazole Walgreen Company ANDA Current 11509-0426 vagistat Tioconazole Combe Incorporated ANDA Current 11673-426 Up and up tioconazole 1 Tioconazole Target Corporation ANDA Current 11822-0426 tioconazole 1 Tioconazole Rite Aid Corporation ANDA Current 11822-0426 tioconazole 1 Tioconazole Rite Aid Corporation ANDA Current 21130-060 signature care tioconazole 1 Tioconazole Safeway ANDA Current 24385-374 Good Neighbor Pharmacy Tioconazole 1 Tioconazole Amerisource Bergen ANDA Current 30142-426 tioconazole 1 tioconazole Kroger Company ANDA Current 36800-426 Topcare Tioconazole 1 Tioconazole Topco Associates LLC ANDA Current 36800-426 Topcare Tioconazole 1 Tioconazole Topco Associates LLC ANDA Current 36800-426 Topcare Tioconazole 1 Tioconazole Topco Associates LLC ANDA Current 37205-296 leader tioconastat 1 Tioconazole Cardinal Health ANDA Current 37808-426 Tioconazole 1 Tioconazole H E B ANDA Current 41163-032 Equaline Tioconazole 1 Tioconazole Supervalu Inc ANDA Current 41190-426 ShopRite Tioconazole 1 Tioconazole Wakefern Food Corporation ANDA Current 41250-426 tioconazole 1 Tioconazole Meijer Distribution Inc ANDA Current 41520-426 CareOne Tioconazole 1 Tioconazole American Sales Company ANDA Current 49035-426 Equate tioconazole 1 day Tioconazole Wal-Mart Stores Inc ANDA Current 49035-426 Equate tioconazole 1 day Tioconazole Wal-Mart Stores Inc ANDA Current 49348-508 SUNMARK TIOCONAZOLE 1 Tioconazole McKesson ANDA Current 49348-508 SUNMARK TIOCONAZOLE 1 Tioconazole Strategic Sourcing Services LLC ANDA Current 49348-508 SUNMARK TIOCONAZOLE 1 Tioconazole Strategic Sourcing Services LLC ANDA Current 49738-088 Smart Sense Tioconazole 1 Tioconazole Kmart Corporation ANDA Current 55312-426 Tioconazole 1 Tioconazole Western Family Foods Inc ANDA Current 55312-426 Tioconazole 1 Tioconazole Western Family Foods Inc ANDA Current 55316-426 healthy accents tioconazole 1 Tioconazole DZA Brands LLC ANDA Current 55910-731 dg health tioconazole 1 Tioconazole Dolgencorp, LLC ANDA Current 55910-731 dg health tioconazole 1 Tioconazole Dolgencorp, LLC ANDA Current 59779-718 tioconazole 1 Tioconazole CVS Pharmacy ANDA Current 63094-0426 TIOCONAZOLE TIOCONAZOLE DPT Laboratories, Ltd. ANDA Current 63736-410 Tioconazole Tioconazole Insight Pharmaceuticals LLC ANDA Current 63736-413 MONISTAT TIOCONAZOLE 1 TIOCONAZOLE Insight Pharmaceuticals LLC ANDA Current 70000-0357 Leader Ticonazole Tioconazole Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0357 Leader Ticonazole Tioconazole Cardinal Health ANDA Current 72288-426 basic care tioconazole Tioconazole Amazon.com Services LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 43035 ORIG 2005-07-22 8831 ORIG 2003-04-16