Application 211594

Type: ANDA
Sponsor: ALVOGEN MALTA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.075MG BASE	No	No
002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.15MG BASE	No	No
003	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.3MG BASE	No	No
004	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.45MG BASE	No	No
005	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.6MG BASE	No	No
006	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.75MG BASE	No	No
007	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	FILM;BUCCAL	EQ 0.9MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 · 203 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211594-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.075MG BASE	FILM / BUCCAL	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211594-002	BUPRENORPHINE HYDROCHLORIDE	EQ 0.15MG BASE	FILM / BUCCAL	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211594-003	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE	FILM / BUCCAL	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211594-004	BUPRENORPHINE HYDROCHLORIDE	EQ 0.45MG BASE	FILM / BUCCAL	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211594-005	BUPRENORPHINE HYDROCHLORIDE	EQ 0.6MG BASE	FILM / BUCCAL	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211594-006	BUPRENORPHINE HYDROCHLORIDE	EQ 0.75MG BASE	FILM / BUCCAL	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211594-007	BUPRENORPHINE HYDROCHLORIDE	EQ 0.9MG BASE	FILM / BUCCAL	2021-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211594-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.075MG BASE	FILM / BUCCAL	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211594-002	BUPRENORPHINE HYDROCHLORIDE	EQ 0.15MG BASE	FILM / BUCCAL	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211594-003	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE	FILM / BUCCAL	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211594-004	BUPRENORPHINE HYDROCHLORIDE	EQ 0.45MG BASE	FILM / BUCCAL	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211594-005	BUPRENORPHINE HYDROCHLORIDE	EQ 0.6MG BASE	FILM / BUCCAL	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211594-006	BUPRENORPHINE HYDROCHLORIDE	EQ 0.75MG BASE	FILM / BUCCAL	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211594-007	BUPRENORPHINE HYDROCHLORIDE	EQ 0.9MG BASE	FILM / BUCCAL	2021-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211594-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.075MG BASE	FILM / BUCCAL	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211594-002	BUPRENORPHINE HYDROCHLORIDE	EQ 0.15MG BASE	FILM / BUCCAL	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211594-003	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE	FILM / BUCCAL	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211594-004	BUPRENORPHINE HYDROCHLORIDE	EQ 0.45MG BASE	FILM / BUCCAL	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211594-005	BUPRENORPHINE HYDROCHLORIDE	EQ 0.6MG BASE	FILM / BUCCAL	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211594-006	BUPRENORPHINE HYDROCHLORIDE	EQ 0.75MG BASE	FILM / BUCCAL	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211594-007	BUPRENORPHINE HYDROCHLORIDE	EQ 0.9MG BASE	FILM / BUCCAL	2021-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211594-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.075MG BASE	FILM / BUCCAL	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211594-002	BUPRENORPHINE HYDROCHLORIDE	EQ 0.15MG BASE	FILM / BUCCAL	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211594-003	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE	FILM / BUCCAL	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211594-004	BUPRENORPHINE HYDROCHLORIDE	EQ 0.45MG BASE	FILM / BUCCAL	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211594-005	BUPRENORPHINE HYDROCHLORIDE	EQ 0.6MG BASE	FILM / BUCCAL	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211594-006	BUPRENORPHINE HYDROCHLORIDE	EQ 0.75MG BASE	FILM / BUCCAL	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211594-007	BUPRENORPHINE HYDROCHLORIDE	EQ 0.9MG BASE	FILM / BUCCAL	2021-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211594-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.075MG BASE	FILM / BUCCAL	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211594-002	BUPRENORPHINE HYDROCHLORIDE	EQ 0.15MG BASE	FILM / BUCCAL	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211594-003	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE	FILM / BUCCAL	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211594-004	BUPRENORPHINE HYDROCHLORIDE	EQ 0.45MG BASE	FILM / BUCCAL	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211594-005	BUPRENORPHINE HYDROCHLORIDE	EQ 0.6MG BASE	FILM / BUCCAL	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211594-006	BUPRENORPHINE HYDROCHLORIDE	EQ 0.75MG BASE	FILM / BUCCAL	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211594-007	BUPRENORPHINE HYDROCHLORIDE	EQ 0.9MG BASE	FILM / BUCCAL	2021-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211594-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.075MG BASE	FILM / BUCCAL	2021-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211594-002	BUPRENORPHINE HYDROCHLORIDE	EQ 0.15MG BASE	FILM / BUCCAL	2021-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211594-003	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE	FILM / BUCCAL	2021-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211594-004	BUPRENORPHINE HYDROCHLORIDE	EQ 0.45MG BASE	FILM / BUCCAL	2021-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211594-005	BUPRENORPHINE HYDROCHLORIDE	EQ 0.6MG BASE	FILM / BUCCAL	2021-08-03	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A211594-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211594-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211594-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211594-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211594-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211594-006	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211594-007	AB	1	`782e0a99824c…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Advagen Pharma Ltd	699638dd-3a53-445f-a545-d0e6eabfe1c9	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	11686845-f5fd-4e96-8a4f-9b132bf48840	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	442831cf-9636-433a-9a12-e9a8cd31f72a	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	9f7b0a28-f937-4d4d-b793-ca3468bd28e0	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
BELBUCA	BUPRENORPHINE HYDROCHLORIDE	BioDelivery Sciences International Inc	bc2b7a3d-72cf-497c-95b0-ba2b71f63c64	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Hospira, Inc.	23aa1bb3-cecf-4e62-29bb-48488bb66fc3	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Buprenorphine Hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Par Health USA, LLC	34767dda-ce52-4f98-a45f-bb5cee0cd5e6	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Buprenorphine Hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	A-S Medication Solutions	c1398d85-d4bb-4426-8ecf-a50400910d81	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	adc1167e-910e-4d7b-abdc-751d3df0c3dc	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Buprenorphine Hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Somerset Therapeutics, LLC	74e40c51-853b-4e7f-b3cb-a27af29e1cbf	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Buprenorphine Hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-400	buprenorphine buccal film	buprenorphine buccal	Alvogen, Inc.	ANDA	Current
47781-425	buprenorphine buccal film	buprenorphine buccal	Alvogen, Inc.	ANDA	Current
47781-471	buprenorphine buccal film	buprenorphine buccal	Alvogen, Inc.	ANDA	Current
47781-472	buprenorphine buccal film	buprenorphine buccal	Alvogen, Inc.	ANDA	Current
47781-473	buprenorphine buccal film	buprenorphine buccal	Alvogen, Inc.	ANDA	Current
47781-474	buprenorphine buccal film	buprenorphine buccal	Alvogen, Inc.	ANDA	Current
47781-475	buprenorphine buccal film	buprenorphine buccal	Alvogen, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66705	ORIG	2021-03-10