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 42.

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.

Product history page 1 of 6 · 210 observed 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
2026-08-18 06:07:40	2026-07	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077712-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-005	AB	1	`2680178bc6a6…`

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 · 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