FDA.reportPublic FDA data

Application 209549

Type
ANDA
Sponsor
WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERIFLUNOMIDETERIFLUNOMIDETABLET;ORAL7MGNoNo
002TERIFLUNOMIDETERIFLUNOMIDETABLET;ORAL14MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209549-001TERIFLUNOMIDETERIFLUNOMIDE7MGTABLET / ORAL2018-07-27
A209549-002TERIFLUNOMIDETERIFLUNOMIDE14MGTABLET / ORAL2018-07-27

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209549-001TERIFLUNOMIDE7MGTABLET / ORAL2018-07-27a50c72e98297…
2026-08-01 22:54:322026-06A209549-002TERIFLUNOMIDE14MGTABLET / ORAL2018-07-27a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TERIFLUNOMIDETERIFLUNOMIDECONCORD BIOTECH LIMITED2d2724f6-8812-4a26-b2ec-936b71f868e12026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TERIFLUNOMIDE
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDEZydus Pharmaceuticals USA Inc.cbf32b27-e63a-4544-9c1f-6564e82200e52026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDEAurobindo Pharma Limited2fd80242-c607-4c50-b497-8259abb4a2f82026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TERIFLUNOMIDETERIFLUNOMIDEAlembic Pharmaceuticals Inc.8c1bc23b-a62b-4172-a603-8b97761514b42026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TERIFLUNOMIDE
generic name: TERIFLUNOMIDE
teriflunomideTERIFLUNOMIDEGlenmark Pharmaceuticals Inc., USAcb431ea0-ba0f-4b5d-a50d-f8c0507622422026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: teriflunomide
generic name: TERIFLUNOMIDE
AubagioTERIFLUNOMIDEGenzyme Corporation4650d12c-b9c8-4525-b07f-a2d773eca1552026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDEAvKAREf9c95ed7-130f-9455-e053-6394a90a182f2026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDEAccord Healthcare Inc.246d42e5-5418-42ba-aff9-ae399b166c692025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDETeva Pharmaceuticals, Inc.c424959d-00c9-4e76-aba6-cc7464d8e9032024-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDEBiocon Pharma Inc.37f04f8b-001e-66ff-4574-cc34cebce61c2024-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDEZydus Lifesciences Limited58991a51-d40e-476f-8f5f-ac89e68e71072024-08-12Name fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDENatco Pharma USA LLC8219b4a2-fb9d-4387-ba33-96d28aad71dd2024-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDECamber Pharmaceuticals, Inc.9b25c24e-a4a9-43b4-a33f-75bef3a96d5f2023-03-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TERIFLUNOMIDETERIFLUNOMIDEAlembic Pharmaceuticals Limited2b084b44-f15b-4b16-b700-4382434f21362023-02-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TERIFLUNOMIDE
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDEMSN LABORATORIES PRIVATE LIMITED63ba28ef-5055-461a-99ef-c49e8ece4b542023-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE
TeriflunomideTERIFLUNOMIDEMylan Pharmaceuticals Inc.1824aae5-58af-43da-8231-435c8f118bc02022-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Teriflunomide
generic name: TERIFLUNOMIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55198ORIG2018-08-17