Home Applications 208400 Application 208400
Type NDA
Sponsor SILVERGATE PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XATMEP METHOTREXATE SODIUM SOLUTION;ORAL EQ 2MG BASE/ML 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 N208400-001 XATMEP METHOTREXATE SODIUM EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208400-001 10231927 2033-01-02 U-1349 2019-04-01 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 N208400-001 12396947 2033-01-02 Drug product 2025-09-15 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 N208400-001 9855215 2033-01-02 Drug product 2018-01-19
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 · 42 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 2026-08-18 06:07:40 2026-07 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208400-001 XATMEP EQ 2MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208400-001 XATMEP EQ 2MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208400-001 XATMEP EQ 2MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208400-001 XATMEP EQ 2MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 8 · 293 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 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 12396947 2033-01-02 Drug product 2025-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 9855215 2033-01-02 Drug product 2018-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 12396947 2033-01-02 Drug product 2025-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 9855215 2033-01-02 Drug product 2018-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 12396947 2033-01-02 Drug product 2025-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 9855215 2033-01-02 Drug product 2018-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 9855215 2033-01-02 Drug product 2018-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xatmep METHOTREXATE Azurity Pharmaceuticals, Inc. aec9984e-34c5-481b-b6bf-9bb5caf1daf8 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208400 application number: NDA208400 ndc (product): 52652-2001
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 52652-2001 Xatmep Methotrexate Silvergate Pharmaceuticals, Inc. NDA Current 52652-2001 Xatmep Methotrexate Azurity Pharmaceuticals, Inc. NDA Current 52652-2001 Xatmep Methotrexate Azurity Pharmaceuticals, Inc. NDA Current 52652-2001 Xatmep Methotrexate Azurity Pharmaceuticals, Inc. NDA Current 52652-2001 Xatmep Methotrexate Silvergate Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 53064 SUPPL 2018-03-20 53046 SUPPL 2018-03-16 50055 ORIG 2017-10-13 50054 ORIG 2017-10-13 48154 ORIG 2017-04-27 48153 ORIG 2017-04-27 48118 ORIG 2017-04-26 48114 ORIG 2017-04-26