Home Applications 079133 Application 079133
Type ANDA
Sponsor SIGMAPHARM LABS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE TABLET;ORAL 5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A079133-001 AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079133-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079133-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB 2009-01-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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.
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 42291-122 Amiloride Hydrochloride Amiloride Hydrochloride AvKARE, Inc. ANDA Current 42794-005 Amiloride Hydrochloride Amiloride Hydrochloride Sigmapharm Laboratories, LLC ANDA Current 42794-005 Amiloride Hydrochloride Amiloride Hydrochloride Sigmapharm Laboratories, LLC ANDA Current 50268-071 Amiloride Hydrochloride Amiloride Hydrochloride AvPAK ANDA Current 64980-151 Amiloride Hydrochloride Amiloride Hydrochloride Rising Pharmaceuticals, Inc ANDA Current