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 3 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	A-S Medication Solutions	bea36ec9-f7fd-4295-bfbd-0228cffcddd7	2026-02-08	Warnings, Adverse reactions	Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Sportpharm LLC	45c4b584-b7e2-4e91-a93d-aff14feb606f	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Sportpharm LLC	50617adc-8528-414d-bb6c-78887d404983	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6e06e73c-b777-4a2d-988f-b009f2fc34d1	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	b70a3a12-76a2-4558-bf2c-eaa38a9ba0a0	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6f530f28-8c10-41dc-818f-1aef2306bde5	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	RedPharm Drug, Inc.	bdacaaa7-b46e-ee0c-e053-2a95a90aea3c	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Zhejiang Yongtai Pharmaceutical Co., Ltd	ccf9708a-ed3b-4786-b3a6-e96125b2f9d5	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Northwind Health Company, LLC	f7f6dc0d-cf8f-50b5-e053-6294a90a9e59	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Northwind Health Company, LLC	f309ccbb-b68a-3190-e053-2995a90a0ad4	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Macleods Pharmaceuticals Limited	c36798a1-b865-4e94-9905-5af024a9e250	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Major Pharmaceuticals	c4aae81f-0219-450f-aa60-953964f74172	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	QPharma, Inc.	fbd0a22f-b365-c0a2-e053-6394a90a1e07	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Golden State Medical Supply, Inc.	98bf51e7-01f8-e3f7-e053-2995a90a42f0	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Macleods Pharmaceuticals Limited	2696f799-7902-4239-807a-9ae85a5d0f1d	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	AvPAK	53ff9f7e-0db0-c841-d334-4cf31f658828	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE DELAYED RELEASE	DOXYCYCLINE HYCLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	f5ee43b2-d6ca-4819-a3d7-07f8421015d7	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Redpharm Drug	44f2fdde-cf84-6f42-e063-6394a90af94e	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	ca63aa91-519d-429f-adfc-a4ec45367294	2025-12-03	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