Application 077712

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No

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

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	TE codes	Approval date
A077712-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31
A077712-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31
A077712-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02
A077712-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13
A077712-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A077712-001	AB
A077712-002	AB
A077712-003	AB
A077712-004	AB
A077712-005	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077712-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077712-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077712-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077712-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077712-005	AB	1	`a50c72e98297…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Strides Pharma Science Limited	f3116ebf-d72c-4e98-aa50-006be4770c86	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Asclemed USA, Inc.	056bdaac-4a43-42f0-9435-f349d3ccc128	2025-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Redpharm Drug	439c2de6-3ea5-e829-e063-6294a90aa77d	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	08977126-9671-4d87-9724-1599ca86e181	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3ca9f0d9-a40d-4416-e063-6394a90aec8b	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	3245cd2f-8ad0-b755-e063-6394a90a603c	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	3a849aeb-b72c-5cde-e063-6394a90a9768	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	32323565-5add-96a9-e063-6294a90a5b4e	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	323148b2-809a-db11-e063-6294a90abe36	2025-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-4990	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-4990	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-4991	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-4991	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-4992	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-4992	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-4993	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-4993	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-4994	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-4994	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0904-6590	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6590	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6591	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6591	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
21695-254	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Rebel Distributors Corp	ANDA	Current
52959-129	Oxycodone Hydrochloride	Oxycodone Hydrochloride	H.J. Harkins Company, Inc.	ANDA	Current
52959-131	Oxycodone Hydrochloride	Oxycodone Hydrochloride	H.J. Harkins Company, Inc.	ANDA	Current
63629-4155	oxycodone hydrochloride	oxycodone hydrochloride	bryant ranch prepack	ANDA	Current
63629-4184	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76152	ORIG	2023-11-03
22609	ORIG	2012-09-12