Home Applications 212379 Application 212379
Type NDA
Sponsor FOAMIX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMZEEQ MINOCYCLINE HYDROCHLORIDE AEROSOL, FOAM;TOPICAL EQ 4% BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N212379-001 AMZEEQ MINOCYCLINE HYDROCHLORIDE EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212379-001 10086080 2030-10-01 U-2647 2019-11-15 N212379-001 10137200 2030-10-01 U-2647 2019-11-15 N212379-001 10213512 2030-10-01 U-2647 Drug product 2019-11-15 N212379-001 10265404 2030-10-01 Drug product 2019-11-15 N212379-001 10517882 2030-10-01 U-2647 2020-01-10 N212379-001 10821187 2030-10-01 U-2647 2020-11-16 N212379-001 8865139 2030-10-01 U-2647 Drug product 2019-11-15 N212379-001 8945516 2030-10-01 Drug product 2019-11-15 N212379-001 8992896 2030-10-01 U-2647 Drug product 2019-11-15 N212379-001 9675700 2030-10-01 U-2647 Drug product 2019-11-15 N212379-001 10398641 2037-09-08 U-2647 2019-11-15 N212379-001 10849847 2037-09-08 U-2647 2020-12-09
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.
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 2026-08-18 06:07:40 2026-07 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212379-001 AMZEEQ EQ 4% BASE AEROSOL, FOAM / TOPICAL RLD, RS 2019-10-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 12 · 463 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N212379-001 10086080 2030-10-01 U-2647 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 10137200 2030-10-01 U-2647 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 10213512 2030-10-01 U-2647 Drug product 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 10265404 2030-10-01 Drug product 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 10517882 2030-10-01 U-2647 2020-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 10821187 2030-10-01 U-2647 2020-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 8865139 2030-10-01 U-2647 Drug product 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 8945516 2030-10-01 Drug product 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 8992896 2030-10-01 U-2647 Drug product 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 9675700 2030-10-01 U-2647 Drug product 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 10398641 2037-09-08 U-2647 2019-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212379-001 10849847 2037-09-08 U-2647 2020-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212379-001 10086080 2030-10-01 U-2647 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 10137200 2030-10-01 U-2647 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 10213512 2030-10-01 U-2647 Drug product 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 10265404 2030-10-01 Drug product 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 10517882 2030-10-01 U-2647 2020-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 10821187 2030-10-01 U-2647 2020-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 8865139 2030-10-01 U-2647 Drug product 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 8945516 2030-10-01 Drug product 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 8992896 2030-10-01 U-2647 Drug product 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 9675700 2030-10-01 U-2647 Drug product 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 10398641 2037-09-08 U-2647 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212379-001 10849847 2037-09-08 U-2647 2020-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 10086080 2030-10-01 U-2647 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 10137200 2030-10-01 U-2647 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 10213512 2030-10-01 U-2647 Drug product 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 10265404 2030-10-01 Drug product 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 10517882 2030-10-01 U-2647 2020-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 10821187 2030-10-01 U-2647 2020-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 8865139 2030-10-01 U-2647 Drug product 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 8945516 2030-10-01 Drug product 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 8992896 2030-10-01 U-2647 Drug product 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 9675700 2030-10-01 U-2647 Drug product 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 10398641 2037-09-08 U-2647 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212379-001 10849847 2037-09-08 U-2647 2020-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212379-001 10086080 2030-10-01 U-2647 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212379-001 10137200 2030-10-01 U-2647 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212379-001 10213512 2030-10-01 U-2647 Drug product 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212379-001 10265404 2030-10-01 Drug product 2019-11-15 6a471c1ec25d…
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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69489-201 AMZEEQ Minocycline Journey Medical Corporation NDA Current 72356-101 AMZEEQ Minocycline Journey Medical Corporation NDA Current 72356-101 AMZEEQ Minocycline VYNE Pharmaceuticals Inc. NDA Current 72356-101 AMZEEQ Minocycline Journey Medical Corporation NDA Current 72356-101 AMZEEQ Minocycline VYNE Pharmaceuticals Inc. NDA Current 72356-101 AMZEEQ Minocycline Journey Medical Corporation NDA Current 72356-101 AMZEEQ Minocycline Journey Medical Corporation NDA Current 72356-101 AMZEEQ Minocycline VYNE Pharmaceuticals Inc. NDA Current 72356-101 AMZEEQ Minocycline Foamix Pharmaceuticals Inc. NDA Current 72356-101 AMZEEQ Minocycline Foamix Pharmaceuticals Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 70396 SUPPL 2022-03-03 70239 SUPPL 2022-02-24 66053 SUPPL 2021-02-01 66038 SUPPL 2021-02-01 62519 ORIG 2020-04-09 60621 ORIG 2019-10-22 60606 ORIG 2019-10-21