Application 202116

Type: ANDA
Sponsor: ALVOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202116-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30
A202116-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30
A202116-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202116-001	AB
A202116-002	AB
A202116-003	AB

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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202116-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2011-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202116-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2011-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202116-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-12-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202116-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202116-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202116-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202116-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202116-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202116-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202116-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202116-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202116-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202116-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202116-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202116-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202116-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202116-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202116-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202116-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202116-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202116-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202116-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202116-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202116-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202116-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202116-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202116-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202116-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202116-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202116-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202116-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202116-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202116-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202116-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202116-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202116-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202116-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202116-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202116-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202116-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202116-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202116-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202116-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone hydrochloride	OXYCODONE HYDROCHLORIDE	Alvogen, Inc.	20bb6bb4-230a-c9c2-01d8-a6e9341e96ba	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202116 application number: ANDA202116 ndc (product): 47781-265 ndc (product): 47781-264 ndc (product): 47781-263
Oxycodone hydrochloride	OXYCODONE HYDROCHLORIDE	Asclemed USA, Inc.	1bb147d4-1ab6-dd70-e063-6394a90a67a8	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202116 application number: ANDA202116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-263	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-263	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-263	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-263	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-263	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-264	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-264	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-264	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-264	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-264	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-265	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-265	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-265	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-265	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
47781-265	Oxycodone hydrochloride	Oxycodone hydrochloride	Alvogen, Inc.	ANDA	Current
68071-2536	Oxycodone hydrochloride	Oxycodone hydrochloride	NuCare Pharmaceuticals,Inc,	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76328	ORIG	2023-11-03