Application 207490

Type: ANDA
Sponsor: ALVOGEN PINE BROOK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	5MCG/HR	No	No
002	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	10MCG/HR	No	No
003	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	15MCG/HR	No	No
004	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	20MCG/HR	No	No
005	BUPRENORPHINE	BUPRENORPHINE	FILM, EXTENDED RELEASE;TRANSDERMAL	7.5MCG/HR	No	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	Approval date
A207490-001	BUPRENORPHINE	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17
A207490-002	BUPRENORPHINE	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17
A207490-003	BUPRENORPHINE	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17
A207490-004	BUPRENORPHINE	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17
A207490-005	BUPRENORPHINE	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL		2023-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A207490-001	AB
A207490-002	AB
A207490-003	AB
A207490-004	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 · 139 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	A207490-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207490-002	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207490-003	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207490-004	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207490-005	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL		2023-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207490-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207490-002	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207490-003	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207490-004	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207490-005	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL		2023-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207490-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207490-002	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207490-003	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207490-004	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207490-005	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL		2023-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207490-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207490-002	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207490-003	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207490-004	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207490-005	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL		2023-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207490-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207490-002	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207490-003	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207490-004	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207490-005	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL		2023-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207490-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207490-002	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207490-003	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207490-004	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207490-005	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL		2023-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207490-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207490-002	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207490-003	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207490-004	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207490-005	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL		2023-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207490-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207490-002	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207490-003	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207490-004	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2022-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207490-005	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL		2023-03-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 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	A207490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207490-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207490-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207490-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207490-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207490-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207490-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207490-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207490-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207490-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207490-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207490-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207490-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207490-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207490-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207490-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207490-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207490-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207490-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207490-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207490-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207490-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207490-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207490-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207490-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207490-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207490-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207490-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207490-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207490-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207490-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207490-004	AB	1	`d06236e962d9…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
buprenorphine transdermal system	BUPRENORPHINE	Alvogen Inc.	315284b8-32ab-d34a-ea02-f501c6131bcc	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207490 application number: ANDA207490 ndc (product): 47781-406 ndc (product): 47781-408 ndc (product): 47781-407 ndc (product): 47781-419

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-406	buprenorphine transdermal system	buprenorphine	Alvogen Inc.	ANDA	Current
47781-407	buprenorphine transdermal system	buprenorphine	Alvogen Inc.	ANDA	Current
47781-408	buprenorphine transdermal system	buprenorphine	Alvogen Inc.	ANDA	Current
47781-419	buprenorphine transdermal system	buprenorphine	Alvogen Inc.	ANDA	Current
58064-408	buprenorphine transdermal system	buprenorphine	LTS Therapy Systems, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76485	ORIG	2023-11-07