Application 201194

Type: NDA
Sponsor: VISTAPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML	Yes	Yes

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
N201194-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-01-12

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-01-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD	2012-01-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201194-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2012-01-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201194-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201194-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201194-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201194-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201194-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201194-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201194-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201194-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201194-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201194-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201194-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201194-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201194-001	AA	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N201194-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201194-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201194-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201194-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201194-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201194-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201194-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201194-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201194-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201194-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201194-001	AA	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201194-001	M-14	2024-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201194-001	M-14	2024-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201194-001	M-14	2024-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201194-001	M-14	2024-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201194-001	M-14	2024-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201194-001	M-14	2024-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201194-001	M-14	2024-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201194-001	M-14	2024-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201194-001	M-14	2024-07-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201194-001	M-14	2024-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201194-001	M-14	2024-07-21	`1c564ffb4f44…`

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 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66689-401	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-401	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-401	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-401	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-401	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-401	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-401	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-403	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-403	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-403	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-403	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-403	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-403	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
66689-403	Oxycodone Hydrochloride	Oxycodone Hydrochloride	VistaPharm, Inc.	NDA	Current
67296-1595	Oxycodone Hydrochloride	Oxycodone Hydrochloride	RedPharm Drug, Inc.	NDA	Current
67296-1595	Oxycodone Hydrochloride	Oxycodone Hydrochloride	RedPharm Drug, Inc.	NDA	Current
67296-1595	Oxycodone Hydrochloride	Oxycodone Hydrochloride	RedPharm Drug, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84674	SUPPL	2026-01-06
84570	SUPPL	2025-12-29
80082	SUPPL	2024-11-04
78213	SUPPL	2024-04-23
78212	SUPPL	2024-04-23
78189	SUPPL	2024-04-22
77072	SUPPL	2023-12-19
76946	SUPPL	2023-12-18
76242	ORIG	2023-11-03
68175	SUPPL	2021-07-23
68174	SUPPL	2021-07-23
68157	SUPPL	2021-07-22
66635	SUPPL	2021-03-08
66634	SUPPL	2021-03-08
66573	SUPPL	2021-03-08
60451	SUPPL	2019-10-09
60399	SUPPL	2019-10-08
60398	SUPPL	2019-10-08
55704	SUPPL	2018-10-01
55703	SUPPL	2018-10-01
55582	SUPPL	2018-09-24
55581	SUPPL	2018-09-24
46419	SUPPL	2016-12-21
46309	SUPPL	2016-12-20
44832	ORIG	2012-08-29
43359	ORIG	2012-08-29
40051	ORIG	2012-01-23
32086	ORIG	2012-01-17