Application 203638

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	30MG	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
A203638-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03
A203638-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03
A203638-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03
A203638-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03
A203638-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203638-001	AB
A203638-002	AB
A203638-003	AB
A203638-004	AB
A203638-005	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 · 205 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
2026-02-19 14:30 UTC	2026-02	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203638-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203638-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-005	AB	1	`5bbf6a4d5a75…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE	Major Pharmaceuticals	6b6db42b-9821-4aa6-8566-297037d84079	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638 ndc (product): 0904-7180 ndc (product): 0904-6966
Oxycodone Hydrochloride	OXYCODONE	Amneal Pharmaceuticals LLC	094b64b3-cd32-4de5-afb6-ea00d9caad74	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638 ndc (product): 65162-048 ndc (product): 65162-049 ndc (product): 65162-051 ndc (product): 65162-047 ndc (product): 65162-050
Oxycodone Hydrochloride	OXYCODONE	Redpharm Drug	525001a6-68d8-7ef7-e063-6294a90abc5f	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Precision Dose, Inc.	f849c7cc-fa85-47eb-be30-1be137913bf9	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638 ndc (product): 68094-005
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	b2510d72-bf63-4c9d-ac5e-7bacd993fa10	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638 ndc (product): 71335-1023
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	232d44d2-3924-4d35-873c-d2aef75e9a41	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	d248ceba-9492-4348-aa07-31c9c73a3620	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638 ndc (product): 71335-1080
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	bc7fdf7e-ad4e-4a04-b35c-2233cc7e5f15	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638 ndc (product): 71335-0981
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	9da42120-0214-45cb-bb98-9a7739e72d43	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638 ndc (product): 71335-0677

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6966	Oxycodone Hydrochloride	Oxycodone	Major Pharmaceuticals	ANDA	Current
0904-6966	Oxycodone Hydrochloride	Oxycodone	Major Pharmaceuticals	ANDA	Current
0904-7180	Oxycodone Hydrochloride	Oxycodone	Major Pharmaceuticals	ANDA	Current
61919-671	OXYCODONE HCL	OXYCODONE HCL	DIRECT RX	ANDA	Current
61919-671	OXYCODONE HCL	OXYCODONE HCL	DIRECT RX	ANDA	Current
61919-820	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-820	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-820	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-821	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-821	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-047	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-048	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-049	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-050	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-051	Oxycodone Hydrochloride	Oxycodone	Amneal Pharmaceuticals LLC	ANDA	Current
68071-5055	Oxycodone Hydrochloride	Oxycodone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5055	Oxycodone Hydrochloride	Oxycodone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68094-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
71335-0677	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0677	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0677	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0981	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0981	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-0981	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1023	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1023	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1023	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1080	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1080	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current
71335-1101	Oxycodone Hydrochloride	Oxycodone	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76337	ORIG	2023-11-03