Application 207494

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 150MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 200MG BASE	No	No
003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 50MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207494-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15
A207494-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15
A207494-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207494-001	AB
A207494-002	AB
A207494-003	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 · 119 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	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 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	A207494-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207494-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207494-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207494-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207494-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207494-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207494-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207494-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207494-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207494-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	0a18d4c7-9484-4d3e-b61b-e81fe63fefec	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207494 application number: ANDA207494 ndc (product): 43547-462 ndc (product): 43547-325 ndc (product): 43547-324
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sonoma Pharmaceuticals, Inc.	4fa26176-a730-48ed-9659-e2f64212f418	2018-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207494 application number: ANDA207494 ndc (product): 69668-515

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-324	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-324	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-324	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-324	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-325	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-325	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-325	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-325	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-462	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-462	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
43547-462	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	ANDA	Current
69668-515	Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sonoma Pharmaceuticals, Inc.	ANDA	Current