FDA.reportPublic FDA data

Application 020647

Type
NDA
Sponsor
SOMERSET

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELDEPRYLSELEGILINE HYDROCHLORIDECAPSULE;ORAL5MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020647-001ELDEPRYLSELEGILINE HYDROCHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1996-05-15

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020647-001ELDEPRYL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1996-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020647-001ELDEPRYL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1996-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020647-001ELDEPRYL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1996-05-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020647-001ELDEPRYL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1996-05-15a50c72e98297…

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
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEGolden State Medical Supply, Inc.040a97e5-efd1-4a2f-b737-2f13e5366d702025-11-24Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEMarlex Pharmaceuticals, Inc.df88d6bf-0fda-3825-e053-2a95a90a3a752025-11-21Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEBryant Ranch Prepackb8eb0a00-adc7-4aaf-987c-fa1b207b29962025-08-18Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEBryant Ranch Prepack4848270a-1179-410c-b4e6-a7e555b3a9882025-07-15Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEA2A Integrated Pharmaceuticalsa59ff47b-4379-44f3-9d2c-f8c6121d18812025-02-28Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDERising Pharma Holdings, Inc.23c4481f-d150-40c6-addb-b3e454ca914f2024-08-07Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEChartwell RX, LLC189ac32d-28b4-47c5-9de6-318e502eff3b2024-05-08Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEi3 Pharmaceuticals, LLCc81e983b-455d-2e65-e053-2a95a90a31232024-03-20Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEA-S Medication Solutionsf286c854-3b8c-44a8-b3b5-c828dbabb2072023-02-06Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEProficient Rx LP57b564ef-c89b-4cf6-a11f-f67391d74e7e2022-04-01Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
ZELAPARSELEGILINE HYDROCHLORIDEBausch Health US, LLC380d7717-2a79-42f3-a712-efe5e7696ba02021-06-01Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDENovitium Pharma LLCe42d99b0-c62e-49d4-b792-1301bb539b922021-04-01Warnings, Adverse reactionsName fallback
generic name: SELEGILINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
35074SUPPL2016-04-14
12921SUPPL2016-04-14
25438SUPPL2009-01-06
2997SUPPL2009-01-06
41521SUPPL1997-08-06