Application 076196

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
003	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No
004	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	TABLET;ORAL	200MG	No	No
005	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	TABLET;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076196-001	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	2003-09-16
A076196-002	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	2003-09-16
A076196-003	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	2003-09-16
A076196-004	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL	2003-09-16
A076196-005	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	2003-09-16

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076196-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	2003-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076196-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	2003-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076196-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	2003-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076196-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL	2003-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076196-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	2003-09-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076196-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	2003-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076196-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	2003-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076196-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	2003-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076196-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL	2003-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076196-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	2003-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076196-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	2003-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076196-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	2003-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076196-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	2003-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076196-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL	2003-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076196-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	2003-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076196-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	2003-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076196-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	2003-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076196-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	2003-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076196-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL	2003-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076196-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	2003-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076196-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	2003-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076196-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	2003-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076196-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	2003-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076196-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL	2003-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076196-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	2003-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076196-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	2003-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076196-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	2003-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076196-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	2003-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076196-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL	2003-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076196-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	2003-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076196-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	2003-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076196-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	2003-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076196-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	2003-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076196-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL	2003-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076196-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	2003-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076196-001	NEFAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	2003-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076196-002	NEFAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	2003-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076196-003	NEFAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	2003-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076196-004	NEFAZODONE HYDROCHLORIDE	200MG	TABLET / ORAL	2003-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076196-005	NEFAZODONE HYDROCHLORIDE	250MG	TABLET / ORAL	2003-09-16	`03ed91905a0d…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nefazodone Hydrochloride	NEFAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	0bd4c34a-4f43-4c84-8b98-1d074cba97d5	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nefazodone Hydrochloride generic name: NEFAZODONE HYDROCHLORIDE
Nefazodone Hydrochloride	NEFAZODONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	51ff7db5-aaf9-4c3c-86e6-958ebf16b60f	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nefazodone Hydrochloride generic name: NEFAZODONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44293	ORIG	2007-05-09