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 2 of 3 · 44 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rugby mometasone furoate nasal MOMETASONE FUROATE Rugby Laboratories b4c43535-ad22-44c2-b04f-df4348a6c485 2025-08-06 Warnings Name fallback generic name: MOMETASONE FUROATE MOMETASONE FUROATE MOMETASONE FUROATE Golden State Medical Supply, Inc. e30ca373-d9c0-4cad-b5c3-3be9c299dddc 2025-07-10 Warnings, Adverse reactions Name fallback brand name: MOMETASONE FUROATE generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Padagis Israel Pharmaceuticals Ltd a12fef6b-681e-4f80-8bcd-3f01733f1a67 2025-07-07 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Sun Pharmaceutical Industries, Inc. ce61920d-65df-4423-925d-091e624ea32e 2025-07-07 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE MOMETASONE FUROATE MOMETASONE FUROATE Aurohealth LLC 48ba8c52-73b6-4ee9-ba13-756a645a9183 2024-11-25 Warnings Name fallback brand name: MOMETASONE FUROATE generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack 43a91066-1d85-4f67-9856-a11c1bb2b22b 2024-11-20 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack 6c7d8133-b71e-4290-bec1-53ff0232998a 2024-08-30 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Childrens Nasonex MOMETASONE FUROATE L. Perrigo Company e15d055e-9a25-46b4-8724-3609cf2dc062 2024-08-28 Warnings Name fallback generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack 45c9512b-9463-4684-bfdb-742644d77cc3 2024-08-14 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Proficient Rx LP 2bf06b19-4ed7-41a3-b6fc-29713c41965c 2024-02-01 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Cosette Pharmaceuticals, Inc. f69603aa-a5a6-b8f3-c9ed-2d0abc9f4d92 2023-11-29 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Cosette Pharmaceuticals, Inc. f5b30e5e-b067-e28c-b7c5-aa58f4c57f09 2023-11-29 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack c3053a64-9044-496e-9005-12b4440d46e8 2023-10-20 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack d15edb8b-c8b2-4023-992e-f79cefa2d1e8 2023-08-16 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack a6055a9c-e19c-48ad-a743-c0a7f7366cdd 2023-07-18 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Bryant Ranch Prepack 5f1f2136-9e10-4d43-bb35-ed285c744fe4 2023-07-18 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE Padagis Israel Pharmaceuticals Ltd 7296b4a2-f180-4887-a8e0-029f81aec566 2023-04-21 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE FUROATE A-S Medication Solutions 9fe65193-b4d8-480b-89b3-178cd1b20713 2023-02-15 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE Sinuva MOMETASONE FUROATE Intersect ENT, Inc. e33c1b23-cdc6-4f64-94ba-24b0b42c09bf 2023-01-26 Warnings, Adverse reactions Name fallback generic name: MOMETASONE FUROATE Mometasone Furoate MOMETASONE Amneal Pharmaceuticals LLC ff41e901-5a6f-4ad5-be8a-a68eae787e5e 2022-08-20 Warnings, Adverse reactions Name fallback brand name: Mometasone Furoate
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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