Home Applications 076411 Application 076411
Type ANDA
Sponsor IMPAX LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHENAMINE HIPPURATE METHENAMINE HIPPURATE TABLET;ORAL 1GM No No
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 A076411-001 METHENAMINE HIPPURATE METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20
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 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2003-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2003-06-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2003-06-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL AB 2003-06-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076411-001 METHENAMINE HIPPURATE 1GM TABLET / ORAL 2003-06-20 e64feba35796…
Observed Orange Book normalized TE history# 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 · 12 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Methenamine Hippurate METHENAMINE HIPPURATE ANI Pharmaceuticals, Inc. a3eeacd4-1983-49ec-a60d-3abaf505ce57 2026-07-27 Warnings, Adverse reactions Name fallback brand name: Methenamine Hippurate generic name: METHENAMINE HIPPURATE Methenamine Hippurate METHENAMINE HIPPURATE NorthStar Rx LLC 3c9e5bea-f61d-48c3-8e05-640eccccf2ba 2026-05-21 Warnings, Adverse reactions Name fallback brand name: Methenamine Hippurate generic name: METHENAMINE HIPPURATE Methenamine Hippurate METHENAMINE HIPPURATE Aurobindo Pharma Limited 9f002ad9-58e7-44f2-a980-3cc3f36bbd9b 2026-04-10 Warnings, Adverse reactions Name fallback brand name: Methenamine Hippurate generic name: METHENAMINE HIPPURATE Methenamine Hippurate METHENAMINE HIPPURATE Jubilant Cadista Pharmaceuticals Inc. 4263d826-7de2-4011-b8ec-ba1f5222f0e6 2026-02-03 Warnings, Adverse reactions Name fallback brand name: Methenamine Hippurate generic name: METHENAMINE HIPPURATE Methenamine Hippurate METHENAMINE HIPPURATE Micro Labs Limited e07ddd63-4725-49db-bec2-bd4f966c6e48 2025-05-13 Warnings, Adverse reactions Name fallback brand name: Methenamine Hippurate generic name: METHENAMINE HIPPURATE Methenamine hippurate METHENAMINE HIPPURATE Zydus Lifesciences Limited 7e0d13d1-e564-4f3e-9054-65161eddfc57 2025-03-12 Name fallback brand name: Methenamine hippurate generic name: METHENAMINE HIPPURATE Methenamine Hippurate METHENAMINE HIPPURATE Alvogen Inc. bc95972d-3db2-122a-0d1c-d7080c251445 2024-11-17 Warnings, Adverse reactions Name fallback brand name: Methenamine Hippurate generic name: METHENAMINE HIPPURATE Methenamine Hippurate METHENAMINE HIPPURATE American Health Packaging fcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be 2024-09-24 Warnings, Adverse reactions Name fallback brand name: Methenamine Hippurate generic name: METHENAMINE HIPPURATE Methenamine hippurate METHENAMINE HIPPURATE Viona Pharmaceuticals Inc 759b3725-0934-4974-a3ac-59a20aee81c6 2024-06-13 Warnings, Adverse reactions Name fallback brand name: Methenamine hippurate generic name: METHENAMINE HIPPURATE METHENAMINE HIPPURATE METHENAMINE HIPPURATE Golden State Medical Supply, Inc. 131a1322-0182-7a4e-e063-6394a90accbf 2024-03-07 Warnings, Adverse reactions Name fallback brand name: METHENAMINE HIPPURATE generic name: METHENAMINE HIPPURATE Methenamine Hippurate METHENAMINE HIPPURATE AvPAK b581b655-62a4-2aa9-e053-2a95a90aa823 2024-01-09 Warnings, Adverse reactions Name fallback brand name: Methenamine Hippurate generic name: METHENAMINE HIPPURATE METHENAMINE HIPPURATE METHENAMINE HIPPURATE Ingenus Pharmaceuticals, LLC 4412d667-63f6-427e-a5c6-376a0e1e172d 2023-05-23 Warnings, Adverse reactions Name fallback brand name: METHENAMINE HIPPURATE generic name: METHENAMINE HIPPURATE
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 0115-1754 Methenamine Hippurate Methenamine Hippurate Amneal Pharmaceuticals of New York LLC ANDA Current 0115-1754 Methenamine Hippurate Methenamine Hippurate Impax Generics ANDA Current 64720-139 Methenamine Hippurate Methenamine Hippurate CorePharma, LLC ANDA Current 64720-139 Methenamine Hippurate Methenamine Hippurate CorePharma, LLC ANDA Current 68151-0984 Methenamine Hippurate Methenamine Hippurate Carilion Materials Management ANDA Current