Application 062269

Type: ANDA
Sponsor: CARIBE HOLDINGS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET;ORAL	EQ 100MG BASE	No	No
003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET;ORAL	EQ 50MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A062269-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08
A062269-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062269-002	AB
A062269-003	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 · 86 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
2026-09-14 22:38:34	2026-08	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		1982-11-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL			1983-10-05	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A062269-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062269-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062269-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062269-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062269-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062269-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062269-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062269-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062269-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062269-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062269-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062269-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062269-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062269-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062269-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062269-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062269-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062269-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062269-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062269-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062269-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062269-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062269-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062269-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062269-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062269-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062269-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062269-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062269-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062269-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062269-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A062269-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062269-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A062269-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062269-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062269-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062269-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062269-003	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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	051654c7-8ba6-44f2-842c-72f515e9b32d	2026-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2305ab4a-7d08-41f6-9c39-c9b6835be389	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269 ndc (product): 70518-3214
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Redpharm Drug	44f2fdde-cf84-6f42-e063-6394a90af94e	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	ca63aa91-519d-429f-adfc-a4ec45367294	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
TARGADOX	DOXYCYCLINE HYCLATE	Journey Medical Corporation	83243f78-b984-46a4-a88a-c6a15c217b90	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269 ndc (product): 69489-111
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	JG Pharma Inc.	10b8bf71-4311-41e8-a891-bab8bc86863f	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	61195fc6-3fa7-4203-b526-477b48395856	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9cbd8699-e2c2-40d4-8797-e676f2a10eb2	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	65cac0b6-3550-48cf-bffa-cf42443c2731	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Epic Pharma, LLC	2b402587-8ecc-4fea-83ad-8071345b6356	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	860a1566-5857-ed88-e053-2991aa0ae2a4	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269 ndc (product): 68071-4836

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0463-6000	Doxycycline Hyclate	Doxycycline Hyclate	C.O. Truxton, Inc.	ANDA	Current
24658-312	Doxycycline Hyclate	Doxycycline Hyclate	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	ANDA	Current
24658-312	Doxycycline Hyclate	Doxycycline Hyclate	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	ANDA	Current
24658-312	Doxycycline Hyclate	Doxycycline Hyclate	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	ANDA	Current
24658-312	Doxycycline Hyclate	Doxycycline Hyclate	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	ANDA	Current
24658-312	Doxycycline Hyclate	Doxycycline Hyclate	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	ANDA	Current
42806-312	Doxycycline Hyclate	Doxycycline Hyclate	Epic Pharma, LLC	ANDA	Current
42806-312	Doxycycline Hyclate	Doxycycline Hyclate	Epic Pharma, LLC	ANDA	Current
42806-312	Doxycycline Hyclate	Doxycycline Hyclate	Epic Pharma, LLC	ANDA	Current
50090-6133	Doxycycline Hyclate	Doxycycline Hyclate	A-S Medication Solutions	ANDA	Current
50090-6134	Doxycycline Hyclate	Doxycycline Hyclate	A-S Medication Solutions	ANDA	Current
53002-2711	Doxycycline Hyclate	Doxycycline Hyclate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2711	Doxycycline Hyclate	Doxycycline Hyclate	RPK Pharmaceuticals, Inc.	ANDA	Current
67296-1801	Doxycycline Hyclate	Doxycycline Hyclate	RedPharm Drug, Inc.	ANDA	Current
67296-1801	Doxycycline Hyclate	Doxycycline Hyclate	RedPharm Drug, Inc.	ANDA	Current
68071-4836	Doxycycline Hyclate	Doxycycline Hyclate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4836	Doxycycline Hyclate	Doxycycline Hyclate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4836	Doxycycline Hyclate	Doxycycline Hyclate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-2112	Doxycycline Hyclate	Doxycycline Hyclate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7474	Doxycycline Hyclate	Doxycycline Hyclate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7474	Doxycycline Hyclate	Doxycycline Hyclate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7474	Doxycycline Hyclate	Doxycycline Hyclate	Preferred Pharmaceuticals Inc.	ANDA	Current
69489-111	TARGADOX	doxycycline hyclate	Journey Medical Corporation	ANDA	Current
69489-111	TARGADOX	doxycycline hyclate	Journey Medical Corporation	ANDA	Current
70518-3214	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
70518-3214	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
70518-3214	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
70934-187	Doxycycline Hyclate	Doxycycline Hyclate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71610-087	Doxycycline Hyclate	Doxycycline Hyclate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-087	Doxycycline Hyclate	Doxycycline Hyclate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72143-211	Doxycycline Hyclate	Doxycycline Hyclate	JG Pharma Inc.	ANDA	Current
72143-211	Doxycycline Hyclate	Doxycycline Hyclate	JG Pharma Inc.	ANDA	Current