Application 021306

Type: NDA
Sponsor: PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTRANS	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	5MCG/HR	Yes	No
002	BUTRANS	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	10MCG/HR	Yes	No
003	BUTRANS	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	20MCG/HR	Yes	Yes
004	BUTRANS	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	15MCG/HR	Yes	No
005	BUTRANS	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	7.5MCG/HR	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021306-001	BUTRANS	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30
N021306-002	BUTRANS	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30
N021306-003	BUTRANS	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30
N021306-004	BUTRANS	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25
N021306-005	BUTRANS	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N021306-001	AB
N021306-002	AB
N021306-003	AB
N021306-004	AB
N021306-005	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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 201 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	N021306-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021306-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-005	AB	1	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	N021306-001	M-250	2020-10-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021306-002	M-250	2020-10-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021306-003	M-250	2020-10-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021306-004	M-250	2020-10-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021306-005	M-250	2020-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021306-001	M-250	2020-10-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021306-002	M-250	2020-10-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021306-003	M-250	2020-10-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021306-004	M-250	2020-10-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021306-005	M-250	2020-10-13	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine	BUPRENORPHINE	Rhodes Pharmaceuticals LLC	2738feae-316e-426f-971c-5f142ac01b60	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021306 application number: NDA021306 ndc (product): 42858-493 ndc (product): 42858-839 ndc (product): 42858-353 ndc (product): 42858-750 ndc (product): 42858-586
Butrans	BUPRENORPHINE	Knoa Pharma LLC	794aa355-66de-41b8-aedf-f2c40f6bc664	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021306 application number: NDA021306 ndc (product): 59011-758 ndc (product): 59011-751 ndc (product): 59011-750 ndc (product): 59011-752 ndc (product): 59011-757

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 62 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3600	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA,	NDA AUTHORIZED	Current
0093-3601	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3602	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-3603	Buprenorphine	Buprenorphine	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
42858-353	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-353	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-353	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-353	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-353	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-493	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-493	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-493	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-493	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-493	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-586	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-586	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-586	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-586	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-586	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-750	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-750	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-750	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-750	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-750	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-839	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-839	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-839	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-839	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
42858-839	Buprenorphine	Buprenorphine	Rhodes Pharmaceuticals L.P.	NDA AUTHORIZED GENERIC	Current
55700-568	Buprenorphine	Buprenorphine	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
55700-579	Buprenorphine	Buprenorphine	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
55700-579	Buprenorphine	Buprenorphine	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
59011-750	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-750	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-750	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-750	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-750	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-750	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-751	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-751	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-751	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-751	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-751	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-751	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-752	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-752	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-752	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-752	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-752	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-752	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-757	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-757	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-757	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-757	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-757	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-757	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-758	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-758	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-758	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-758	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-758	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current
59011-758	Butrans	buprenorphine	Purdue Pharma LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84684	SUPPL	2026-01-06
84601	SUPPL	2025-12-31
80095	SUPPL	2024-11-04
77002	SUPPL	2023-12-19
76905	SUPPL	2023-12-18
76904	SUPPL	2023-12-18
71410	SUPPL	2022-06-21
71409	SUPPL	2022-06-21
71368	SUPPL	2022-06-21
66595	SUPPL	2021-03-08
66594	SUPPL	2021-03-08
66549	SUPPL	2021-03-05
60347	SUPPL	2019-10-08
60337	SUPPL	2019-10-08
60336	SUPPL	2019-10-08
55983	SUPPL	2018-10-17
55982	SUPPL	2018-10-17
55681	SUPPL	2018-10-01
55680	SUPPL	2018-10-01
50081	SUPPL	2017-10-18
50073	SUPPL	2017-10-18
49487	SUPPL	2017-08-21
48591	SUPPL	2017-05-31
46356	SUPPL	2016-12-21
46280	SUPPL	2016-12-20
45464	SUPPL	2016-10-04
27443	SUPPL	2016-04-22
27442	SUPPL	2015-07-06
4991	SUPPL	2014-08-20
36630	SUPPL	2014-07-02
15158	SUPPL	2014-07-02
27440	SUPPL	2014-07-01
4990	SUPPL	2014-07-01
4989	SUPPL	2014-04-17
15160	SUPPL	2014-04-16
15159	SUPPL	2013-07-30
27441	SUPPL	2013-07-29
27439	SUPPL	2013-04-16
36629	SUPPL	2012-07-12
27438	SUPPL	2012-07-11
44640	ORIG	2011-09-26
42091	ORIG	2011-09-26
27437	SUPPL	2011-07-07
27436	SUPPL	2011-07-07
36628	SUPPL	2011-07-06
15157	SUPPL	2011-07-06
23992	ORIG	2010-08-05
15156	ORIG	2010-07-06
27435	ORIG	2010-07-02
52071	SUPPL	1900-01-01
52070	SUPPL	1900-01-01