Application 205806

Type: ANDA
Sponsor: DR REDDYS LABS SA

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 4MG BASE;EQ 1MG BASE	No	No
002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 12MG BASE;EQ 3MG 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
A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB		2018-06-14
A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB		2018-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205806-001	AB
A205806-002	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 3 · 82 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	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205806-001	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205806-002	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	2018-06-14	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A205806-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205806-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205806-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205806-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205806-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205806-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205806-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205806-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205806-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205806-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205806-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205806-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205806-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205806-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205806-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205806-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205806-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205806-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205806-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205806-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205806-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205806-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205806-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205806-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205806-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205806-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205806-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205806-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205806-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205806-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205806-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205806-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205806-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205806-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205806-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205806-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205806-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205806-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205806-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205806-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Dr.Reddys Laboratories Inc	72dc1ec0-7c59-a587-4ffd-c40ef79e6fb2	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205806 application number: ANDA205806 ndc (product): 43598-581 ndc (product): 43598-580

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-580	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current
43598-580	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current
43598-580	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current
43598-580	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current
43598-580	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current
43598-581	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current
43598-581	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current
43598-581	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current
43598-581	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current
43598-581	Buprenorphine and Naloxone	Buprenorphine and Naloxone	Dr.Reddys Laboratories Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76377	ORIG	2023-11-06
54626	ORIG	2018-06-20