Home Applications 077401 Application 077401
Type ANDA
Sponsor ACP NIMBLE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MOMETASONE FUROATE MOMETASONE FUROATE OINTMENT;TOPICAL 0.1% 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 A077401-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077401-001 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 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0713-0635 Mometasone Furoate Mometasone Furoate Cosette Pharmaceuticals, Inc. ANDA Current 0713-0635 Mometasone Furoate Mometasone Furoate Cosette Pharmaceuticals, Inc. ANDA Current 0713-0635 Mometasone Furoate Mometasone Furoate G&W Laboratories, Inc. ANDA Current 0713-0635 Mometasone Furoate Mometasone Furoate Cosette Pharmaceuticals, Inc. ANDA Current 0713-0727 Mometasone Furoate Mometasone Furoate Almus ANDA Current 0713-0727 Mometasone Furoate Mometasone Furoate Cosette Pharmaceuticals, Inc. ANDA Current 0713-0727 Mometasone Furoate Mometasone Furoate Cosette Pharmaceuticals, Inc. ANDA Current 0713-0727 Mometasone Furoate Mometasone Furoate Cosette Pharmaceuticals, Inc. ANDA Current 42254-175 Mometasone Furoate Mometasone Furoate Rebel Distributors Corp ANDA Current 68258-3997 Mometasone Furoate Mometasone Furoate Dispensing Solutions, Inc. ANDA Current 70518-0531 Mometasone Furoate Mometasone Furoate REMEDYREPACK INC. ANDA Current