Application 209402

Type: ANDA
Sponsor: CHANGZHOU PHARM

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
A209402-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2019-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209402-001	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.

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	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209402-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209402-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209402-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209402-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209402-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209402-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209402-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209402-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209402-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209402-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209402-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209402-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209402-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209402-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209402-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209402-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209402-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209402-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209402-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209402-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209402-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209402-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209402-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209402-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209402-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209402-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209402-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209402-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209402-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209402-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209402-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209402-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209402-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209402-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209402-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209402-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209402-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209402-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209402-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209402-001	AB	1	`a50c72e98297…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	f0fbf63a-e75c-40cf-b2e9-429deaac899d	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402 ndc (product): 70518-3488
doxycycline	DOXYCYCLINE	A-S Medication Solutions	fe8cd3c6-36d6-4d92-bc5c-833cd6f9cb32	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	bcc95094-80ed-4023-b2a6-955a4810bfbe	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	d3c0b756-30ba-4ef9-a178-fd785d720373	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	ST. MARY'S MEDICAL PARK PHARMACY	00b2aa98-dea2-90c3-e063-6294a90a35d6	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	7f882f1a-fe75-4592-9df5-f0e4bf1d232e	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	A-S Medication Solutions	1c998ca8-1df6-4b3c-9533-f4500cc1079a	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	Cranbury Pharmaceuticals, LLC	43ceb0ee-268a-424c-a6a8-88e824c5ed04	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402 ndc (product): 27808-233
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Diirect_rx	1b403f4b-1c61-3991-e063-6394a90ae4f2	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	1df9e905-d2e7-4a5a-8bd6-43f4850ba900	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402 ndc (product): 71335-2100
doxycycline	DOXYCYCLINE	Proficient Rx LP	716dccec-7480-44dd-91b9-249ae2c25088	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	Asclemed USA, Inc.	f33ae6f5-bdb6-4c15-9e62-6180433bb1fb	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27808-233	doxycycline	doxycycline	Tris Pharma Inc	ANDA	Current
42582-216	Doxycycline Hyclate	Doxycycline Hyclate	Bi-Coastal Pharma International, LLC	ANDA	Current
42582-216	Doxycycline Hyclate	Doxycycline Hyclate	Bi-Coastal Pharma International, LLC	ANDA	Current
55488-0186	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Changzhou Pharmaceutical Factory	ANDA	Current
55488-0186	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Changzhou Pharmaceutical Factory	ANDA	Current
68071-2750	doxycycline	doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2750	doxycycline	doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2750	doxycycline	doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2750	doxycycline	doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2761	doxycycline	doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2761	doxycycline	doxycycline	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3488	doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-3488	doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-3488	doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
71335-2100	doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current