Application 211785

Type: ANDA
Sponsor: MYLAN TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 2MG BASE;EQ 0.5MG BASE	No	No
002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 4MG BASE;EQ 1MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB		2020-04-17
A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB		2020-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211785-001	AB
A211785-002	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 2 · 74 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	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211785-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211785-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2020-04-17	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A211785-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211785-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211785-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211785-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211785-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211785-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211785-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211785-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211785-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211785-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211785-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211785-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211785-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211785-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211785-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211785-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211785-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211785-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211785-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211785-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211785-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211785-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211785-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211785-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211785-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211785-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211785-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211785-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211785-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211785-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211785-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211785-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211785-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211785-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211785-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211785-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211785-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211785-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211785-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211785-002	AB	1	`87673890dc5c…`

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 and Naloxone	BUPRENORPHINE AND NALOXONE	Redpharm Drug	300ae3d0-464c-d0be-e063-6294a90a7f9d	2026-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211785 application number: ANDA211785
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Mylan Pharmaceuticals Inc.	557d8d4d-8751-431c-b18e-9d5cf23fc579	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211785 application number: ANDA211785 ndc (product): 0378-8765 ndc (product): 0378-8766

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8765	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8765	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8765	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8766	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8766	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8766	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76394	ORIG	2023-11-06