FDA.reportPublic FDA data

Application 021336

Type
NDA
Sponsor
SOMERSET

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMSAMSELEGILINEFILM, EXTENDED RELEASE;TRANSDERMAL6MG/24HRYesYes
002EMSAMSELEGILINEFILM, EXTENDED RELEASE;TRANSDERMAL9MG/24HRYesNo
003EMSAMSELEGILINEFILM, EXTENDED RELEASE;TRANSDERMAL12MG/24HRYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021336-001EMSAMSELEGILINE6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-27
N021336-002EMSAMSELEGILINE9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27
N021336-003EMSAMSELEGILINE12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021336-002EMSAM9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021336-003EMSAM12MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2006-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021336-001EMSAM6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2006-02-278072bd15b7f6…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMSAMSELEGILINEViatris Specialty LLCb891bd9f-fdb8-4862-89c5-ecdd700398a32020-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021336
application number: NDA021336
ndc (product): 49502-901
ndc (product): 49502-902
ndc (product): 49502-900

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49502-900EMSAMselegilineMylan Specialty L.P.NDACurrent
49502-900EMSAMselegilineMylan Specialty L.P.NDACurrent
49502-900EMSAMselegilineMylan Specialty L.P.NDACurrent
49502-901EMSAMselegilineMylan Specialty L.P.NDACurrent
49502-901EMSAMselegilineMylan Specialty L.P.NDACurrent
49502-901EMSAMselegilineMylan Specialty L.P.NDACurrent
49502-902EMSAMselegilineMylan Specialty L.P.NDACurrent
49502-902EMSAMselegilineMylan Specialty L.P.NDACurrent
49502-902EMSAMselegilineMylan Specialty L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49013SUPPL2017-07-18
49012SUPPL2017-07-18
49003SUPPL2017-07-17
36682SUPPL2015-04-01
27509SUPPL2015-04-01
36681SUPPL2014-09-30
27508SUPPL2014-09-16
5070SUPPL2014-09-16
5069SUPPL2008-02-14
21607ORIG2007-09-10
27507SUPPL2007-08-02
15210SUPPL2007-07-31
23645ORIG2007-05-09
36680ORIG2006-03-03
27506ORIG2006-03-03
51656SUPPL1900-01-01
51654SUPPL1900-01-01
51653SUPPL1900-01-01
51652SUPPL1900-01-01