Application 207289

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE;ORAL	EQ 100MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207289-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207289-001	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 · 42 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	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A207289-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207289-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207289-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207289-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207289-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207289-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207289-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207289-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207289-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207289-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207289-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207289-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207289-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207289-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207289-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207289-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207289-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207289-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207289-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207289-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207289-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207289-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207289-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207289-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207289-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207289-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207289-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207289-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207289-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207289-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207289-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207289-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207289-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207289-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207289-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207289-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207289-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207289-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207289-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207289-001	AB	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE	Bryant Ranch Prepack	f9a9a558-4063-4aa7-9191-3875c97cf49a	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289 ndc (product): 71335-0861
Doxycycline Hyclate	DOXYCYCLINE	Amneal Pharmaceuticals NY LLC	49ecbf95-58e8-4f3c-b5d5-650a15d866cb	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289 ndc (product): 60219-1100
Doxycycline Hyclate	DOXYCYCLINE	Amneal Pharmaceuticals NY LLC	79f3c026-7687-4a11-8d2e-03493531d3bf	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289 ndc (product): 69238-1100
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	b4f2ab4f-c32b-6435-e053-2995a90a69b6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289 ndc (product): 80425-0114
Doxycycline Hyclate	DOXYCYCLINE	Proficient Rx LP	e2151005-fb4a-485d-88ad-b44c4594d579	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289 ndc (product): 71205-385

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4592	Doxycycline Hyclate	Doxycycline	A-S Medication Solutions	ANDA	Current
50090-4592	Doxycycline Hyclate	Doxycycline	A-S Medication Solutions	ANDA	Current
50090-4599	Doxycycline Hyclate	Doxycycline	A-S Medication Solutions	ANDA	Current
50436-1100	Doxycycline Hyclate	Doxycycline	Unit Dose Services	ANDA	Current
60219-1100	Doxycycline Hyclate	Doxycycline	Amneal Pharmaceuticals NY LLC	ANDA	Current
63629-7751	Doxycycline Hyclate	Doxycycline	Bryant Ranch Prepack	ANDA	Current
63629-7751	Doxycycline Hyclate	Doxycycline	Bryant Ranch Prepack	ANDA	Current
67296-1762	Doxycycline Hyclate	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
67296-1762	Doxycycline Hyclate	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
68071-4354	Doxycycline Hyclate	Doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4354	Doxycycline Hyclate	Doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4354	Doxycycline Hyclate	Doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4478	Doxycycline Hyclate	Doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
69238-1100	Doxycycline Hyclate	Doxycycline	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1100	Doxycycline Hyclate	Doxycycline	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1100	Doxycycline Hyclate	Doxycycline	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1100	Doxycycline Hyclate	Doxycycline	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1100	Doxycycline Hyclate	Doxycycline	Amneal Pharmaceuticals NY LLC	ANDA	Current
70518-1378	Doxycycline Hyclate	Doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-1378	Doxycycline Hyclate	Doxycycline	REMEDYREPACK INC.	ANDA	Current
70934-085	Doxycycline Hyclate	Doxycycline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-085	Doxycycline Hyclate	Doxycycline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-085	Doxycycline Hyclate	Doxycycline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-385	Doxycycline Hyclate	Doxycycline	Proficient Rx LP	ANDA	Current
71205-385	Doxycycline Hyclate	Doxycycline	Proficient Rx LP	ANDA	Current
71205-385	Doxycycline Hyclate	Doxycycline	Proficient Rx LP	ANDA	Current
71205-385	Doxycycline Hyclate	Doxycycline	Proficient Rx LP	ANDA	Current
71335-0861	Doxycycline Hyclate	Doxycycline	Bryant Ranch Prepack	ANDA	Current
71335-0861	Doxycycline Hyclate	Doxycycline	Bryant Ranch Prepack	ANDA	Current
71335-0861	Doxycycline Hyclate	Doxycycline	Bryant Ranch Prepack	ANDA	Current
80425-0114	Vibramycin	Doxycycline Hyclate 100mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0114	Doxycycline Hyclate	Doxycycline Hyclate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0114	Doxycycline Hyclate	Doxycycline Hyclate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0114	Doxycycline Hyclate	Doxycycline Hyclate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current