Application 209396

Type: ANDA
Sponsor: MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 75MG BASE	No	No
003	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 100MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209396-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29
A209396-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29
A209396-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209396-001	AB
A209396-002	AB
A209396-003	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 4 · 129 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	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209396-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209396-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209396-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209396-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209396-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209396-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209396-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209396-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209396-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209396-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209396-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209396-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209396-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209396-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209396-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209396-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209396-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209396-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209396-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209396-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209396-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209396-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209396-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209396-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209396-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209396-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209396-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209396-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209396-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209396-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209396-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209396-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209396-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209396-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209396-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209396-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209396-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209396-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209396-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209396-001	AB	1	`301d65b070ca…`

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 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	bcc65910-30d8-4807-ab61-607a56382924	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	5f22094e-9297-4d1b-a37c-7846481b321e	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	1df9e905-d2e7-4a5a-8bd6-43f4850ba900	2024-08-21	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Proficient Rx LP	716dccec-7480-44dd-91b9-249ae2c25088	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	4b170180-21f4-4ee5-9e81-1607ab52cfca	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	5f989cc1-48ae-41bb-b297-2f8c83760b6d	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Lannett Company, Inc.	4999bbd9-44ed-4749-9730-be2337bdf490	2024-07-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Alembic Pharmaceuticals Limited	8e78dc54-8322-435d-8879-4bfe37f1b98c	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	NuCare Pharmaceuticals,Inc.	fa1da527-7a0f-8ed6-e053-6394a90a1b62	2024-02-09	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Proficient Rx LP	c707566b-dbc7-4dac-bad1-952f2f4d6845	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Lupin Pharmaceuticals,Inc.	6512bf22-c211-4127-a8c8-2419656580f6	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	6aab6fee-791e-4141-b55f-685ec9d8712a	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Proficient Rx LP	b83c4c4b-2885-43e7-b1c9-0b3bbf75528d	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Asclemed USA, Inc.	f33ae6f5-bdb6-4c15-9e62-6180433bb1fb	2023-05-04	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Alembic Pharmaceuticals Limited	3dfa486c-4665-4882-93ac-9259708f899c	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	6ae11b4e-1c13-440b-a050-d76e062b0f92	2022-11-05		Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE	Proficient Rx LP	e2151005-fb4a-485d-88ad-b44c4594d579	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	b256babb-1bba-4b0c-8837-d13ba3af7659	2021-02-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	a7b754e2-a028-469d-ba95-8412ef03ab0a	2021-02-02	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	b0894010-39bd-459f-8563-cf83343105ee	2020-06-04	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-040	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current
51862-040	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current
51862-040	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current
51862-041	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current
51862-041	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current
51862-041	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current
51862-041	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current
51862-042	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current
51862-042	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current
51862-042	Doxycycline	Doxycycline	Mayne Pharma Inc.	ANDA	Current