Application 210758

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML	No	No
002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	SOLUTION;ORAL	100MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210758-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2018-04-30
A210758-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA		2018-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210758-001	AA
A210758-002	AA

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 3 · 86 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	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210758-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210758-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2018-04-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210758-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210758-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210758-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210758-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210758-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210758-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210758-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210758-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210758-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210758-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210758-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210758-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210758-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210758-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210758-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210758-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210758-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210758-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210758-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210758-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210758-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210758-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210758-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210758-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210758-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210758-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210758-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210758-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210758-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210758-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210758-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210758-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210758-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210758-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210758-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210758-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210758-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210758-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210758-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210758-002	AA	1	`74a2ff9319b5…`

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 4 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	3eddd18b-695a-4e53-a76c-f6779515b918	2024-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ef58f422-682e-6896-e053-2a95a90a1f2d	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	1bcddbe1-c453-43ec-a822-9e993b885a5f	2024-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	261132f9-ab96-4901-a660-a80c3e0f9d86	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone hydrochloride	OXYCODONE HYDROCHLORIDE	Asclemed USA, Inc.	1bb147d4-1ab6-dd70-e063-6394a90a67a8	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	b2510d72-bf63-4c9d-ac5e-7bacd993fa10	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	232d44d2-3924-4d35-873c-d2aef75e9a41	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	d248ceba-9492-4348-aa07-31c9c73a3620	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	bc7fdf7e-ad4e-4a04-b35c-2233cc7e5f15	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	9da42120-0214-45cb-bb98-9a7739e72d43	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	17f7946d-e889-b736-e063-6394a90a42e0	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	801cb437-c189-44f5-83eb-a51c365d8a6b	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Novel Laboratories, Inc.	69410bf3-0d3a-41f9-b10a-c4ee3770f728	2023-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	391701e5-2035-43fa-91ce-d27a1af19492	2023-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Epic Pharma, LLC	cff1eee3-7c02-4f6c-acc5-1f6dcbab92c0	2022-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc	e5c8e72d-4ac5-4ca3-9557-6a659d4d8338	2021-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Ascent Pharmaceuticals Inc	de96e2be-66d9-4bcb-a133-221ad32e09f1	2017-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-8556	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8556	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8556	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8556	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8556	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8556	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8557	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8557	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8557	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8557	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8557	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current
0406-8557	Oxycodone Hydrochloride	Oxycodone Hydrochloride	SpecGx LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76435	ORIG	2023-11-07