Application 204603

Type: ANDA
Sponsor: NOVEL LABS INC

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 42.

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
A204603-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL			2015-04-29

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 · 42 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
2026-08-18 06:07:40	2026-07	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2015-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204603-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2015-04-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204603-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204603-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204603-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204603-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204603-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204603-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204603-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204603-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204603-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204603-001	AA	1	`ea99ee380514…`

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	Lupin Pharmaceuticals, Inc.	3eddd18b-695a-4e53-a76c-f6779515b918	2024-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204603 application number: ANDA204603 ndc (product): 43386-920

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0920	Oxycodone Hydrochloride	Oxycodone Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0920	Oxycodone Hydrochloride	Oxycodone Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
40032-920	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Novel Laboratories, Inc.	ANDA	Current
43386-920	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
43386-920	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76130	ORIG	2023-11-03