Application 065425

Type: ANDA
Sponsor: AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No
002	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	TABLET;ORAL	300MG	No	Yes

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
A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27
A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065425-001	AB
A065425-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`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	A065425-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065425-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065425-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065425-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065425-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065425-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065425-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065425-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065425-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065425-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065425-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065425-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065425-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065425-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065425-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065425-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065425-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065425-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065425-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065425-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065425-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065425-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065425-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065425-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065425-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065425-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065425-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065425-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065425-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065425-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065425-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065425-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065425-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065425-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065425-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065425-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065425-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065425-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065425-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065425-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Demeclocycline Hydrochloride	DEMECLOCYCLINE	Amneal Pharmaceuticals of New York LLC	539add06-e0a0-401a-b4f6-20776084aa9c	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065425 application number: ANDA065425 ndc (product): 53746-555 ndc (product): 53746-554
Demeclocycline Hydrochloride	DEMECLOCYCLINE	Amneal Pharmaceuticals LLC	4ff23e3b-e111-47fd-9776-1d89d6da049b	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065425 application number: ANDA065425 ndc (product): 65162-555 ndc (product): 65162-554
Demeclocycline Hydrochloride	DEMECLOCYCLINE	American Health Packaging	e6adaf70-5ff9-4395-bff1-0f332090cb80	2024-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065425 application number: ANDA065425 ndc (product): 60687-691 ndc (product): 60687-705

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6180	Demeclocycline Hydrochloride	Demeclocycline	Major Pharmaceuticals	ANDA	Current
0904-6180	Demeclocycline Hydrochloride	Demeclocycline	Major Pharmaceuticals	ANDA	Current
0904-6649	Demeclocycline Hydrochloride	Demeclocycline	Major Pharmaceuticals	ANDA	Current
0904-6649	Demeclocycline Hydrochloride	Demeclocycline	Major Pharmaceuticals	ANDA	Current
42291-264	Demeclocycline Hydrochloride	Demeclocycline	AvKARE, Inc.	ANDA	Current
42291-265	Demeclocycline Hydrochloride	Demeclocycline	AvKARE, Inc.	ANDA	Current
42291-265	Demeclocycline Hydrochloride	Demeclocycline	AvKARE, Inc.	ANDA	Current
53746-554	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-554	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-555	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-555	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals of New York LLC	ANDA	Current
60687-691	Demeclocycline Hydrochloride	Demeclocycline	American Health Packaging	ANDA	Current
60687-691	Demeclocycline Hydrochloride	Demeclocycline	American Health Packaging	ANDA	Current
60687-705	Demeclocycline Hydrochloride	Demeclocycline	American Health Packaging	ANDA	Current
62584-159	Demeclocycline Hydrochloride	Demeclocycline Hydrochloride	American Health Packaging	ANDA	Current
62584-159	Demeclocycline Hydrochloride	Demeclocycline Hydrochloride	American Health Packaging	ANDA	Current
62584-159	Demeclocycline Hydrochloride	Demeclocycline Hydrochloride	American Health Packaging	ANDA	Current
62584-163	Demeclocycline Hydrochloride	Demeclocycline Hydrochloride	American Health Packaging	ANDA	Current
62584-163	Demeclocycline Hydrochloride	Demeclocycline Hydrochloride	American Health Packaging	ANDA	Current
62584-163	Demeclocycline Hydrochloride	Demeclocycline Hydrochloride	American Health Packaging	ANDA	Current
65162-554	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals LLC	ANDA	Current
65162-554	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals LLC	ANDA	Current
65162-554	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals LLC	ANDA	Current
65162-554	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals LLC	ANDA	Current
65162-555	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals LLC	ANDA	Current
65162-555	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals LLC	ANDA	Current
65162-555	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals LLC	ANDA	Current
65162-555	Demeclocycline Hydrochloride	Demeclocycline	Amneal Pharmaceuticals LLC	ANDA	Current
68151-0155	Demeclocycline Hydrochloride	Demeclocycline Hydrochloride	Carilion Materials Management	ANDA	Current