Application 211749

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211749-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA		2019-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211749-001	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 2 · 43 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	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211749-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2019-02-04	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A211749-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211749-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211749-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211749-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211749-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211749-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211749-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211749-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211749-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211749-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211749-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211749-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211749-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211749-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211749-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211749-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211749-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211749-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211749-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211749-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211749-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211749-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211749-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211749-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211749-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211749-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211749-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211749-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211749-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211749-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211749-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211749-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211749-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211749-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211749-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211749-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211749-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211749-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211749-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211749-001	AA	1	`f41ea6bd6efb…`

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 2 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	Rhodes Pharmaceuticals LLC	a5162476-1217-41c0-bc7e-0a0f123f069f	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Roxicodone	OXYCODONE HYDROCHLORIDE	SpecGx LLC	5a8157d3-ba20-4abf-b0d4-6ad141b31d63	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	ff7f1268-ddb7-4742-beee-8b12966fe8f9	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Genus Lifesciences Inc.	6869fec9-1837-4221-afd8-5cc6fadd025d	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	6de58d48-d6fc-46b4-ab7c-9ffdede855dc	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	a1e539ba-2cb5-4815-8c58-37abfd978fa5	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	7503ef9d-0fad-421f-951a-f35ab71f71c7	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	22f9eeaa-8aad-44f6-8258-e41edb60f876	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	e0079cc8-3642-47f0-9d14-28fd8f212c21	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	1a190488-3444-43b0-b9c8-45c1eb371aad	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	35030c55-47e6-44cb-9d96-0c3cd5d0c238	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	bdade691-3687-3308-e053-2995a90ad6ed	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	819ed9fc-0a21-4ed0-9080-91912c5f8ce2	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	MAJOR PHARMACEUTICALS	e4fbf3fd-8755-4699-9a61-ba7fada0f93f	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	5df92fed-6194-4905-9ef2-9eed0d2e8086	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride	OXYCODONE HYDROCHLORIDE	Hikma Pharmceuticals USA Inc.	d8e87c66-f872-4e1d-9ade-ef11490af63b	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: oxycodone hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Eywa Pharma Inc	685f409f-946f-4b7e-8130-5ad7b92a5e7a	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Camber Pharmaceuticals Inc	01db4606-d49c-4b10-a78a-1cf41880a9fb	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	MAJOR PHARMACEUTICALS	6d249bc5-79c4-4c42-a71b-d667c75163db	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
RoxyBond	OXYCODONE HYDROCHLORIDE	Protega Pharmaceuticals Inc	72398542-8e0a-47b2-afeb-9ca5a1f15083	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-625	Oxycodone	Oxycodone	Ascend Laboratories, LLC	ANDA	Current
67877-625	Oxycodone	Oxycodone	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76436	ORIG	2023-11-07