Home Applications 076387 Application 076387
Type ANDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLOTRIMAZOLE CLOTRIMAZOLE TROCHE/LOZENGE;ORAL 10MG No Yes
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 A076387-001 CLOTRIMAZOLE CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076387-001 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.
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 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076387-001 CLOTRIMAZOLE 10MG TROCHE/LOZENGE / ORAL AB RS 2004-07-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0054-4146 Clotrimazole Clotrimazole West-Ward Pharmaceuticals Corp. ANDA Current 0054-4146 Clotrimazole Clotrimazole Hikma Pharmacuticals USA USA Inc. ANDA Current 0054-4146 Clotrimazole Clotrimazole West-Ward Pharmaceuticals Corp. ANDA Current 0054-8146 Clotrimazole Clotrimazole West-Ward Pharmaceuticals Corp. ANDA Current 0054-8146 Clotrimazole Clotrimazole Hikma Pharmacuticals USA USA Inc. ANDA Current 0054-8146 Clotrimazole Clotrimazole West-Ward Pharmaceuticals Corp. ANDA Current 55154-4951 Clotrimazole Clotrimazole Cardinal Health ANDA Current 55154-4951 Clotrimazole Clotrimazole Cardinal Health ANDA Current 55154-4951 Clotrimazole Clotrimazole Cardinal Health ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 43071 ORIG 2006-10-26 8904 ORIG 2004-07-30