FDA.reportPublic FDA data

Application 215035

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BENZOATEAMLODIPINE BENZOATESUSPENSION;ORAL1MG/ML(150ML)NoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215035-001AMLODIPINE BENZOATEAMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-138072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215035-001AMLODIPINE BENZOATEEQ 1MG BASE/MLSUSPENSION / ORAL2023-06-13a50c72e98297…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73132ORIG2023-01-10