Application 212429

Type: ANDA
Sponsor: AUROLIFE PHARMA 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 44.

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
A212429-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2020-01-27
A212429-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL			2020-01-27

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 2 of 2 · 80 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
2022-03-09 01:35 UTC	2022-03	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2020-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2020-01-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2020-01-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212429-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2020-01-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212429-002	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2020-01-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A212429-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212429-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212429-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212429-002	AA	1	`c0c555d07b60…`

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 Oral Solution	OXYCODONE HYDROCHLORIDE ORAL SOLUTION	Aurolife Pharma, LLC	0b3fa92e-8351-4401-860d-4bba8a7155e6	2024-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212429 application number: ANDA212429 ndc (product): 13107-262 ndc (product): 13107-261

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
13107-261	Oxycodone Hydrochloride Oral Solution	Oxycodone Hydrochloride Oral Solution	Aurolife Pharma, LLC	ANDA	Current
13107-262	Oxycodone Hydrochloride Oral Solution	Oxycodone Hydrochloride Oral Solution	Aurolife Pharma, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76470	ORIG	2023-11-07