Application 202662

Type: ANDA
Sponsor: EPIC PHARMA LLC

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	30MG	No	No
005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	20MG	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	TE codes	Approval date
A202662-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22
A202662-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22
A202662-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22
A202662-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22
A202662-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202662-001	AB
A202662-002	AB
A202662-003	AB
A202662-004	AB
A202662-005	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 · 215 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
2026-09-14 22:38:34	2026-08	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-004	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202662-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2017-04-27	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A202662-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202662-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202662-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202662-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202662-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202662-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202662-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202662-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202662-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202662-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202662-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202662-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202662-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202662-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202662-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202662-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202662-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202662-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202662-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202662-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202662-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202662-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202662-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202662-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202662-005	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202662-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202662-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202662-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202662-004	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202662-005	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202662-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202662-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202662-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202662-004	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202662-005	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202662-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202662-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202662-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202662-004	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202662-005	AB	1	`ea1830bbd6c7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Epic Pharma, LLC	cff1eee3-7c02-4f6c-acc5-1f6dcbab92c0	2022-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202662 application number: ANDA202662 ndc (product): 42806-006 ndc (product): 42806-008 ndc (product): 42806-005 ndc (product): 42806-009 ndc (product): 42806-007

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6743	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Major Pharmaceuticals	ANDA	Current
42806-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-005	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-006	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-006	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-006	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-007	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-007	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-007	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-008	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-008	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-008	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-009	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-009	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-009	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Epic Pharma, LLC	ANDA	Current
61919-444	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-444	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-479	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Direct_Rx	ANDA	Current
71335-1009	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1009	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76330	ORIG	2023-11-03
40206	ORIG	2015-11-25
10091	ORIG	2015-09-24