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 3 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	Strides Pharma Science Limited	f3116ebf-d72c-4e98-aa50-006be4770c86	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXAYDO	OXYCODONE HYDROCHLORIDE	Zyla Life Sciences US LLC	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	2026-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone hydrochloride	OXYCODONE HYDROCHLORIDE	Alvogen, Inc.	20bb6bb4-230a-c9c2-01d8-a6e9341e96ba	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Asclemed USA, Inc.	056bdaac-4a43-42f0-9435-f349d3ccc128	2025-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Aurolife Pharma, LLC	96ad4352-fff3-46a7-85de-466cc161045e	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Redpharm Drug	3745020d-df8c-7209-e063-6394a90aabd7	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Redpharm Drug	439c2de6-3ea5-e829-e063-6294a90aa77d	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1	2025-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	American Health Packaging	aa7ac2bf-d9ed-445d-b394-4d3fe39780ca	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	08977126-9671-4d87-9724-1599ca86e181	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3cd01fb7-b59c-fc5d-e063-6394a90a21d2	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3ca9f0d9-a40d-4416-e063-6394a90aec8b	2025-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	DIRECT RX	a8206207-ad09-83df-e053-2995a90a78b7	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	RedPharm Drug, Inc.	92614a3a-331d-16ad-e053-2a95a90a47cc	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	American Health Packaging	0a6b0659-6816-4f44-81bd-9bac4da5380d	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	e2e52a0e-a80b-4225-b034-37a62f839d92	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Asclemed USA, Inc.	c10cc127-8756-4ddc-9f46-1e003ef271dc	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Quality Care Products LLC	4cadb809-157d-49cc-97b4-3276594f19d2	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Precision Dose, Inc.	f849c7cc-fa85-47eb-be30-1be137913bf9	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	d9841f2d-d182-4888-9a3c-68e1afb3e19c	2024-11-20	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 · 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