FDA.reportPublic FDA data

Application 219531

Type
NDA
Sponsor
BRILLIAN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SDAMLOAMLODIPINE BESYLATEFOR SOLUTION;ORALEQ 2.5MG BASE/BOTYesYes
002SDAMLOAMLODIPINE BESYLATEFOR SOLUTION;ORALEQ 5MG BASE/BOTYesYes
003SDAMLOAMLODIPINE BESYLATEFOR SOLUTION;ORALEQ 10MG BASE/BOTYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219531-001SDAMLOAMLODIPINE BESYLATEEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24
N219531-002SDAMLOAMLODIPINE BESYLATEEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24
N219531-003SDAMLOAMLODIPINE BESYLATEEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24

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
2026-09-14 22:38:342026-08N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-2484e616aacf4f…
2026-09-14 22:38:342026-08N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-2484e616aacf4f…
2026-09-14 22:38:342026-08N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-2484e616aacf4f…
2026-08-18 06:07:402026-07N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD2025-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD2025-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD2025-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-246a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219531-001SDAMLOEQ 2.5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219531-002SDAMLOEQ 5MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219531-003SDAMLOEQ 10MG BASE/BOTFOR SOLUTION / ORALRLD, RS2025-07-24a50c72e98297…

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 6 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC132c078d-7d31-a6f2-e063-6294a90af0952024-03-08Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack52daa759-3327-461a-8cfc-3c6253df91ec2024-03-05Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATETeva Pharmaceuticals, Inc.47edc328-2444-4ca1-a5c1-7c83141e105c2024-03-01Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepack498a9b21-34b9-4373-930b-5ed43201a3452024-01-09Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepacke8958997-f098-44ce-8c21-b7064d1a962e2024-01-09Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions5c50c3fe-afe5-459e-95c0-c9af4cbb69092023-11-13Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions4512feee-a09d-4244-bc03-c43193e53a0e2023-09-20Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd830173d-7676-4490-ab3d-d3515df9ad2e2023-09-07Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee12023-09-07Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LPced6d26e-8c54-4808-88b6-446344f4acd02023-06-01Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATEAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC186b6149-9610-4380-9bf2-9416460692762023-05-04Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCb597d1e1-aba1-4272-bed7-4c95e8150d582023-04-19Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine besylateAMLODIPINE BESYLATEExelan Pharmaceuticals, Inc.efd9eda5-f497-45a3-ae13-dee729add9992023-03-23Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
NorvascAMLODIPINE BESYLATEViatris Specialty LLC7367289c-b0b0-466a-83e2-558e2985c29f2023-02-15Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATEUnichem Pharmaceuticals (USA), Inc.a516b336-8f60-4b86-8921-c7d6c07629f22022-12-05Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCf3482709-c5c3-4bd0-8067-ad57f31bb5252022-10-18Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP445d1274-7249-476b-ad90-ff93aee56f6d2022-06-01Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d62022-04-01Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine besylateAMLODIPINE BESYLATEExelan Pharmaceuticals, Inc.1a24433f-4464-4c6d-9456-ed1ce38e8ec42022-03-12Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LPc2c51ec3-ffb0-4240-b048-a8e424775a762021-08-01Warnings, Adverse reactionsName fallback
generic name: AMLODIPINE BESYLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85871SUPPL 2026-05-11
83798ORIG 2025-10-17
82960ORIG 2025-07-28
82942ORIG 2025-07-25