Application 205777

Type: NDA
Sponsor: PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TARGINIQ	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;10MG	Yes	No
002	TARGINIQ	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;20MG	Yes	No
003	TARGINIQ	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MG;40MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N205777-001	TARGINIQ	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23
N205777-002	TARGINIQ	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23
N205777-003	TARGINIQ	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205777-002	TARGINIQ	10MG;20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205777-003	TARGINIQ	20MG;40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205777-001	TARGINIQ	5MG;10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-07-23	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 960 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205777-001	9073933	2025-03-30	Drug substance	2015-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205777-001	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205777-002	9073933	2025-03-30	Drug substance	2015-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205777-002	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205777-003	9073933	2025-03-30	Drug substance	2015-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205777-003	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205777-001	9073933	2025-03-30	Drug substance	2015-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205777-001	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205777-002	9073933	2025-03-30	Drug substance	2015-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205777-002	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205777-003	9073933	2025-03-30	Drug substance	2015-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205777-003	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205777-001	9073933	2025-03-30	Drug substance	2015-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205777-001	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205777-002	9073933	2025-03-30	Drug substance	2015-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205777-002	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205777-003	9073933	2025-03-30	Drug substance	2015-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205777-003	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205777-001	9073933	2025-03-30	Drug substance	2015-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205777-001	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205777-002	9073933	2025-03-30	Drug substance	2015-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205777-002	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205777-003	9073933	2025-03-30	Drug substance	2015-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205777-003	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205777-001	9073933	2025-03-30	Drug substance	2015-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205777-001	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205777-002	9073933	2025-03-30	Drug substance	2015-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205777-002	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205777-003	9073933	2025-03-30	Drug substance	2015-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205777-003	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205777-001	9073933	2025-03-30	Drug substance	2015-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205777-001	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205777-002	9073933	2025-03-30	Drug substance	2015-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205777-002	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205777-003	9073933	2025-03-30	Drug substance	2015-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205777-003	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205777-001	9073933	2025-03-30	Drug substance	2015-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205777-001	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205777-002	9073933	2025-03-30	Drug substance	2015-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205777-002	9522919	2025-03-30	Drug substance, Drug product	2016-12-20	`5bbf6a4d5a75…`

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55667	SUPPL	2018-09-28
55666	SUPPL	2018-09-28
55549	SUPPL	2018-09-21
55548	SUPPL	2018-09-21
55547	SUPPL	2018-09-21
55546	SUPPL	2018-09-21
48587	SUPPL	2017-05-31
46576	SUPPL	2016-12-29
46437	SUPPL	2016-12-21
46324	SUPPL	2016-12-20
45454	SUPPL	2016-10-03
32723	SUPPL	2016-04-22
24127	ORIG	2015-11-04
10501	SUPPL	2015-07-07
44598	ORIG	2015-06-30
23002	ORIG	2014-08-27
32722	SUPPL	2014-08-20
32721	ORIG	2014-07-23
19684	ORIG	2014-07-23