Application 209385

Type: ANDA
Sponsor: NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;5MG	No	No
002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;7.5MG	No	No
003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A209385-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2018-07-02
A209385-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02
A209385-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2018-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209385-001	AA
A209385-002	AA
A209385-003	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 3 of 4 · 132 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
2020-11-12 02:37 UTC	2020-11	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A209385-001	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209385-002	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209385-003	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209385-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209385-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209385-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209385-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209385-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209385-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209385-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209385-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209385-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209385-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209385-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209385-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209385-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209385-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209385-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209385-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209385-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209385-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209385-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209385-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209385-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209385-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209385-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209385-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209385-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209385-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209385-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209385-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209385-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209385-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209385-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209385-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209385-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209385-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209385-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209385-003	AA	1	`d06236e962d9…`
2019-12-13 00:20 UTC	2019-12	A209385-001	AA	1	`74a2ff9319b5…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride and Acetaminophen	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	40a68a27-4422-5ba0-e063-6294a90ac550	2026-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209385 application number: ANDA209385
Oxycodone Hydrochloride and Acetaminophen	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	40a882d6-a4db-1ad9-e063-6394a90a7268	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209385 application number: ANDA209385
Oxycodone Hydrochloride and Acetaminophen	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	53de17b1-6d5b-c7c0-e063-6394a90a7064	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209385 application number: ANDA209385
Oxycodone Hydrochloride and Acetaminophen	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	Elite Laboratories, Inc.	27fa8190-d334-4bb9-b277-d1f44db433e3	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209385 application number: ANDA209385 ndc (product): 64850-622 ndc (product): 64850-621 ndc (product): 64850-623

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64850-621	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-621	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-621	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-621	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-621	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-622	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-622	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-622	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-622	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-622	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-623	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-623	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-623	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-623	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current
64850-623	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Elite Laboratories, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76217	ORIG	2023-11-03