Application 209243

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET;ORAL	EQ 75MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET;ORAL	EQ 150MG 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
A209243-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL			2019-04-15
A209243-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL			2019-04-15

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2019-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2019-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2019-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2019-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2019-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2019-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209243-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2019-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209243-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2019-04-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209243-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209243-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209243-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209243-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209243-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209243-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209243-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209243-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209243-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209243-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209243-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209243-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209243-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209243-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209243-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209243-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209243-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209243-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209243-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209243-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209243-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209243-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209243-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209243-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209243-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209243-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209243-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209243-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209243-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209243-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209243-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209243-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209243-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209243-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209243-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209243-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209243-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209243-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209243-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209243-002	AB	1	`87673890dc5c…`

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 5 of 8 · 145 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Larken Laboratories, Inc.	49f82130-6f8a-412c-b625-e75906e74675	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	b612d2f5-b703-47f0-b5eb-b66a7aeed577	2025-06-27	Warnings, Adverse reactions	Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Actavis Pharma, Inc.	a569ba80-ffea-40b2-9fbe-a42810b1fccb	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	294c6fc3-e7ca-46ea-b062-a27dd7b0bc97	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	6772807d-a39e-47ce-9584-a08e7f8940d2	2025-06-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	bed39bae-64c2-44b4-9c95-682ead4e6738	2025-05-31	Warnings, Adverse reactions	Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	a5571acf-3284-4559-8cc0-b4856ac6d94d	2025-05-31	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	61195fc6-3fa7-4203-b526-477b48395856	2025-05-16	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9cbd8699-e2c2-40d4-8797-e676f2a10eb2	2025-05-16	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	7c33c1b8-100e-4df8-be8d-de3eed7ced94	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	cec4368f-2852-443d-9d6f-7ba95807021b	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	b3294889-e8f8-42f1-9bd0-13d87572997a	2025-04-15	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	65cac0b6-3550-48cf-bffa-cf42443c2731	2025-04-14	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Mayne Pharma Commercial LLC	cd2ab9b8-9619-4199-8a5d-83377b3274d1	2025-04-14	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	325d5331-d48e-1bc4-e063-6394a90a65b9	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	bff3f426-44fc-4dbf-96df-df44011103e8	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Epic Pharma, LLC	2b402587-8ecc-4fea-83ad-8071345b6356	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Actavis Pharma, Inc.	c2b08332-3256-4658-965a-ede3d973a388	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	e726157e-ce44-4df3-8161-7016700dd751	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	EPIC PHARMA, LLC	b3cd7b44-db40-4ce5-895e-d4c85a0068ae	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-4382	Doxycycline Hyclate	Doxycycline Hyclate	Apotex Corp.	ANDA	Current
60505-4382	Doxycycline Hyclate	Doxycycline Hyclate	Apotex Corp.	ANDA	Current
60505-4384	Doxycycline Hyclate	Doxycycline Hyclate	Apotex Corp.	ANDA	Current
60505-4384	Doxycycline Hyclate	Doxycycline Hyclate	Apotex Corp.	ANDA	Current