FDA.reportPublic FDA data

Application 214897

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMANTADINEAMANTADINECAPSULE, EXTENDED RELEASE;ORAL65.5MGNoNo
002AMANTADINEAMANTADINECAPSULE, EXTENDED RELEASE;ORAL137MGNoNo

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

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
A214897-001AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORAL2024-08-26

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 22:38:342026-08A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORAL2024-08-2684e616aacf4f…
2026-08-18 06:07:402026-07A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORAL2024-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORAL2024-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORAL2024-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORAL2024-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-08-26d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214897-001AMANTADINE HYDROCHLORIDEEQ 68.5MG BASECAPSULE, EXTENDED RELEASE / ORAL2024-08-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214897-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214897-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214897-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214897-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214897-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214897-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214897-001AB1d06236e962d9…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOCOVRIAMANTADINESupernus Pharmaceuticals, Inc.2bee0631-0028-1314-e063-6394a90aaaed2026-09-08Warnings, Adverse reactionsName fallback
generic name: AMANTADINE
GOCOVRIAMANTADINEAdamas Pharma, LLC82ff865f-78f3-4c94-b6a9-727a54944b282026-09-08Warnings, Adverse reactionsName fallback
generic name: AMANTADINE
AmantadineAMANTADINEAmerican Health Packaging5119801d-a5cb-4adf-96b2-08cc3a0ba5942026-06-23Warnings, Adverse reactionsName fallback
brand name: Amantadine
generic name: AMANTADINE
AmantadineAMANTADINEProficient Rx LP7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece2026-02-01Warnings, Adverse reactionsName fallback
brand name: Amantadine
generic name: AMANTADINE
AmantadineAMANTADINENCS HealthCare of KY, LLC dba Vangard Labs2ff05131-f634-4688-86e9-9bc33a8d11c42026-01-23Warnings, Adverse reactionsName fallback
brand name: Amantadine
generic name: AMANTADINE
AmantadineAMANTADINEAvPAK48c949e3-86e0-c639-e063-6294a90acdba2026-01-19Warnings, Adverse reactionsName fallback
brand name: Amantadine
generic name: AMANTADINE
AmantadineAMANTADINEAlembic Pharmaceuticals Inc.da1837b5-fda2-48e0-91ba-d6eb2b991b552025-07-28Warnings, Adverse reactionsName fallback
brand name: Amantadine
generic name: AMANTADINE
amantadineAMANTADINEAlembic Pharmaceuticals Inc.4157d9a7-a53f-4dde-b051-fe3e9a6749132025-06-04Warnings, Adverse reactionsName fallback
brand name: amantadine
generic name: AMANTADINE
AmantadineAMANTADINEXttrium Laboratories, Inc25dd8a3c-6b11-2ea1-e063-6294a90a50cf2025-05-21Warnings, Adverse reactionsName fallback
brand name: Amantadine
generic name: AMANTADINE
AmantadineAMANTADINECoupler LLC303c5b9d-5761-9fcd-e063-6394a90a8a2b2025-03-13Warnings, Adverse reactionsName fallback
brand name: Amantadine
generic name: AMANTADINE
AmantadineAMANTADINEAlembic Pharmaceuticals Limited48fa07c8-8b95-40d7-a0f5-132577dfb2c82023-01-27Warnings, Adverse reactionsName fallback
brand name: Amantadine
generic name: AMANTADINE
amantadineAMANTADINEAlembic Pharmaceuticals Limitedd8887814-3e56-447e-8bc3-add1861e0cf72023-01-27Warnings, Adverse reactionsName fallback
brand name: amantadine
generic name: AMANTADINE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72739ORIG2022-11-28