FDA.reportPublic FDA data

Application 219556

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL150MGNoNo
002OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL300MGNoNo
003OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL600MGNoNo

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
A219556-001OXCARBAZEPINEOXCARBAZEPINE150MGTABLET / ORALAB2026-03-02
A219556-002OXCARBAZEPINEOXCARBAZEPINE300MGTABLET / ORALAB2026-03-02
A219556-003OXCARBAZEPINEOXCARBAZEPINE600MGTABLET / ORALAB2026-03-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A219556-001AB
A219556-002AB
A219556-003AB

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 22:38:342026-08A219556-001OXCARBAZEPINE150MGTABLET / ORALAB2026-03-0284e616aacf4f…
2026-09-14 22:38:342026-08A219556-002OXCARBAZEPINE300MGTABLET / ORALAB2026-03-0284e616aacf4f…
2026-09-14 22:38:342026-08A219556-003OXCARBAZEPINE600MGTABLET / ORALAB2026-03-0284e616aacf4f…
2026-08-18 06:07:402026-07A219556-001OXCARBAZEPINE150MGTABLET / ORALAB2026-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A219556-002OXCARBAZEPINE300MGTABLET / ORALAB2026-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A219556-003OXCARBAZEPINE600MGTABLET / ORALAB2026-03-02caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219556-001OXCARBAZEPINE150MGTABLET / ORALAB2026-03-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219556-002OXCARBAZEPINE300MGTABLET / ORALAB2026-03-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219556-003OXCARBAZEPINE600MGTABLET / ORALAB2026-03-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219556-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A219556-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A219556-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A219556-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219556-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219556-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219556-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219556-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219556-003AB1a50c72e98297…

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 4 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack38694974-3dc6-42b5-bdf9-b5354e35330b2024-10-25Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEDirect_rx21b0cc84-b64a-75de-e063-6294a90a9dd02024-09-09Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepackd8edaa2b-3bab-4030-a4e3-0c77f76557312024-07-16Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEXLCare Pharmaceuticals Inc.9f5d17e4-ca68-48e2-9e87-d3ab1c59aa932024-07-16Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack78f196d4-110e-45b1-813a-725f52c1a4eb2024-04-04Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepackd3c7a3b8-b9a2-4a5f-98b3-0ed02eca34332024-04-02Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEBiocon Pharma Inc.62dfed1d-4c5b-446d-97b3-bad9c33959ff2024-03-20Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack255f64ba-7667-48e6-8599-3b598bf6f4e92024-01-12Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.682a1210-b26e-426e-8ffe-d25d91bdd6082024-01-09Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEPrecision Dose, Inc.636fc847-b3d2-4255-a959-d75499fdb1982023-11-20Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEProficient Rx LP95867dcd-fd0e-4570-987b-d35939f7d7d12022-11-01Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEKanchan Healthcare Inc7be73d22-f87b-4459-a91c-37c1e34db230Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE

Reported adverse events (FAERS/openFDA)#

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