Application 218442

Type: ANDA
Sponsor: BIOCON PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	OXCARBAZEPINE	OXCARBAZEPINE	TABLET;EXTENDED RELEASE	300MG	No	No
003	OXCARBAZEPINE	OXCARBAZEPINE	TABLET;EXTENDED RELEASE	600MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	38694974-3dc6-42b5-bdf9-b5354e35330b	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Direct_rx	21b0cc84-b64a-75de-e063-6294a90a9dd0	2024-09-09	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	d8edaa2b-3bab-4030-a4e3-0c77f7655731	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	XLCare Pharmaceuticals Inc.	9f5d17e4-ca68-48e2-9e87-d3ab1c59aa93	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	78f196d4-110e-45b1-813a-725f52c1a4eb	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	d3c7a3b8-b9a2-4a5f-98b3-0ed02eca3433	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Biocon Pharma Inc.	62dfed1d-4c5b-446d-97b3-bad9c33959ff	2024-03-20	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	255f64ba-7667-48e6-8599-3b598bf6f4e9	2024-01-12	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Breckenridge Pharmaceutical, Inc.	682a1210-b26e-426e-8ffe-d25d91bdd608	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Precision Dose, Inc.	636fc847-b3d2-4255-a959-d75499fdb198	2023-11-20	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Proficient Rx LP	95867dcd-fd0e-4570-987b-d35939f7d7d1	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Kanchan Healthcare Inc	7be73d22-f87b-4459-a91c-37c1e34db230		Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE

Reported adverse events (FAERS/openFDA)#

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