Application 040288

Type: ANDA
Sponsor: VINTAGE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYDONE	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	400MG;5MG	No	No
002	ZYDONE	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	400MG;7.5MG	No	No
003	ZYDONE	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	400MG;10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040288-001	ZYDONE	ACETAMINOPHEN; HYDROCODONE BITARTRATE	400MG;5MG	TABLET / ORAL	1998-11-27
A040288-002	ZYDONE	ACETAMINOPHEN; HYDROCODONE BITARTRATE	400MG;7.5MG	TABLET / ORAL	1998-11-27
A040288-003	ZYDONE	ACETAMINOPHEN; HYDROCODONE BITARTRATE	400MG;10MG	TABLET / ORAL	1998-11-27

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A040288-001	ZYDONE	400MG;5MG	TABLET / ORAL	1998-11-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040288-002	ZYDONE	400MG;7.5MG	TABLET / ORAL	1998-11-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040288-003	ZYDONE	400MG;10MG	TABLET / ORAL	1998-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040288-001	ZYDONE	400MG;5MG	TABLET / ORAL	1998-11-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A040288-002	ZYDONE	400MG;7.5MG	TABLET / ORAL	1998-11-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A040288-003	ZYDONE	400MG;10MG	TABLET / ORAL	1998-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040288-001	ZYDONE	400MG;5MG	TABLET / ORAL	1998-11-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040288-002	ZYDONE	400MG;7.5MG	TABLET / ORAL	1998-11-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040288-003	ZYDONE	400MG;10MG	TABLET / ORAL	1998-11-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040288-001	ZYDONE	400MG;5MG	TABLET / ORAL	1998-11-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040288-002	ZYDONE	400MG;7.5MG	TABLET / ORAL	1998-11-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040288-003	ZYDONE	400MG;10MG	TABLET / ORAL	1998-11-27	`a50c72e98297…`

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
29915	ORIG	1998-11-27