Home Applications 077061 Application 077061
Type ANDA
Sponsor FOUGERA PHARMS 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 43 .
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 A077061-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077061-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077061-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2005-03-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 3 · 45 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Allergy MOMETASONE FUROATE Amazon.com Services LLC b4d548fa-374d-407f-8a41-f04bf6a0e7a4 2026-08-27 Warnings Name fallback generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Padagis Israel Pharmaceuticals Ltd d986282f-da3c-43b6-a3f6-40886d4a1915 2026-08-27 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Nasonex MOMETASONE FUROATE L. Perrigo Company 13696a8b-366a-4a5e-adea-d5b7bff9e46f 2026-08-19 Warnings Name fallback generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Torrent Pharmaceuticals Limited 18ef90de-f74d-492f-a125-49da1875bd29 2026-08-06 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Preferred Pharmaceuticals Inc. 831f7694-8153-4a79-a453-48020b26f035 2026-07-17 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Preferred Pharmaceuticals Inc. bfe3d098-a5f8-4e5d-9fa6-eac167bad3e9 2026-07-17 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE ASMANEX MOMETASONE FUROATE Organon LLC 10b36fb2-6b0d-4f20-b197-3564d6f594b9 2026-07-07 Warnings, Adverse reactions Name fallback generic name: MOMETASONE FUROATE ASMANEX HFA MOMETASONE FUROATE Organon LLC 0c6d63da-41bc-4894-bead-198e66c848ac 2026-07-07 Warnings, Adverse reactions Name fallback generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack 5eda1256-001a-4f40-b3ca-15349d532033 2026-05-21 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone furoate MOMETASONE FUROATE Encube Ethicals, Inc. dae3eaea-fc17-48a2-ae30-2a68f7811bce 2026-04-06 Warnings, Adverse reactions Name fallback brand name: Mometasone furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Sportpharm LLC f02dea3f-9e4f-4c5a-bea3-f428afca803b 2026-03-19 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Preferred Pharmaceuticals Inc. ad47cceb-e471-48d6-85d6-e4a3f10e2ac6 2026-01-27 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE A-S Medication Solutions 16e134c7-39fb-4d16-9c24-a6df438967bf 2026-01-23 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE ALLERGY RELIEF MOMETASONE FUROATE CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 97681a68-c26a-4ec9-ac67-4480878fa43d 2026-01-05 Warnings Name fallback generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack c953bd40-8a52-4812-837a-baaf1b17b3aa 2025-10-29 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack 88f5622d-64da-42b7-8aa9-62a5da5ebfbb 2025-10-24 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE MOMETASONE FUROATE MOMETASONE FUROATE Encube Ethicals, Inc. 1ebaac16-432e-4e92-9d58-718bd76ae368 2025-09-15 Warnings, Adverse reactions Name fallback brand name: MOMETASONE FUROATE generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack 79e13e15-5bd3-48b1-877a-1cd92abbc7c5 2025-09-08 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack 2f79063c-f7da-4e71-b054-d24b86dd386a 2025-09-05 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Leader Allergy Nasal MOMETASONE FUROATE Cardinal Health 110, LLC. dba Leader 26f929e8-0759-4584-a0bf-f7709baa6bee 2025-08-11 Warnings Name fallback generic name: MOMETASONE FUROATE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0168-0271 Mometasone Furoate mometasone furoate E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0271 Mometasone Furoate mometasone furoate E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0271 Mometasone Furoate mometasone furoate E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 70518-0175 Mometasone Furoate mometasone furoate REMEDYREPACK INC. ANDA Current 70518-0175 Mometasone Furoate mometasone furoate REMEDYREPACK INC. ANDA Current