Application 205601

Type: ANDA
Sponsor: RHODES PHARMS

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	TABLET;SUBLINGUAL	EQ 2MG BASE;EQ 0.5MG BASE	No	No
002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 8MG BASE;EQ 2MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB		2020-03-30
A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2020-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205601-001	AB
A205601-002	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 · 76 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
2026-08-18 06:07:40	2026-07	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205601-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205601-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2020-03-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205601-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205601-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205601-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205601-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205601-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205601-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205601-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205601-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205601-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205601-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205601-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205601-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205601-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205601-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205601-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205601-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205601-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205601-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205601-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205601-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205601-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205601-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205601-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205601-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205601-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205601-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205601-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205601-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205601-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205601-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205601-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205601-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205601-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205601-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205601-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205601-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205601-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205601-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205601-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205601-002	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Bryant Ranch Prepack	fe023dbf-e165-4b7f-a211-bd14696f1e2c	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Bryant Ranch Prepack	4b1df792-f56c-4c0c-92b0-a887f4225567	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Bryant Ranch Prepack	17419c34-23a3-429c-8037-150f42536ec7	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Bryant Ranch Prepack	dd3bfccd-86a1-413f-affd-187f81dd07aa	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601 ndc (product): 63629-9483
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Bryant Ranch Prepack	dd6e4fc9-a6f7-458a-b075-d736ce8b7172	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601 ndc (product): 63629-9482
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	REMEDYREPACK INC.	072b2c2e-a564-4bb4-8954-9349a7923807	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601 ndc (product): 70518-3389
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Rhodes Pharmaceuticals LLC	794724a6-0fba-bc8d-ecdb-9e3be8ea2191	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601 ndc (product): 42858-601 ndc (product): 42858-602
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Bryant Ranch Prepack	63aaa6cc-8574-4990-8239-6fdeffce92c8	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Unit Dose Solutions, Inc.	4b301ad7-ac0e-f849-e063-6394a90a27d5	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Redpharm Drug	374530e2-3b2e-77d7-e063-6394a90a37c9	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	American Health Packaging	b05b0087-c0ef-40be-9bf3-3933f6cd3492	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205601 application number: ANDA205601 ndc (product): 60687-626 ndc (product): 60687-637

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-601	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-601	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-601	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Rhodes Parmaceuticals L.P.	ANDA	Current
42858-601	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-602	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-602	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-602	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Rhodes Parmaceuticals L.P.	ANDA	Current
42858-602	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Rhodes Pharmaceuticals L.P.	ANDA	Current
60687-626	Buprenorphine and Naloxone	Buprenorphine and Naloxone	American Health Packaging	ANDA	Current
60687-637	Buprenorphine and Naloxone	Buprenorphine and Naloxone	American Health Packaging	ANDA	Current
63629-9482	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Bryant Ranch Prepack	ANDA	Current
63629-9482	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Bryant Ranch Prepack	ANDA	Current
63629-9483	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Bryant Ranch Prepack	ANDA	Current
70518-3389	Buprenorphine and Naloxone	Buprenorphine and Naloxone	REMEDYREPACK INC.	ANDA	Current
70518-3389	Buprenorphine and Naloxone	Buprenorphine and Naloxone	REMEDYREPACK INC.	ANDA	Current
70518-3487	Buprenorphine and Naloxone	Buprenorphine and Naloxone	REMEDYREPACK INC.	ANDA	Current
70518-3487	Buprenorphine and Naloxone	Buprenorphine and Naloxone	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76393	ORIG	2023-11-06