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 3 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Camber Pharmaceuticals, Inc.	0faee97d-2707-48fe-a739-143cd1a1c4e3	2025-11-27	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE	Bryant Ranch Prepack	f9a9a558-4063-4aa7-9191-3875c97cf49a	2025-11-19	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Steriscience Specialties Private Limited	6d1f7b0f-b71d-4cee-803b-fe418d000c9c	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Cranbury Pharmaceuticals, LLC	43ceb0ee-268a-424c-a6a8-88e824c5ed04	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Henry Schein, Inc	dd70368b-1949-4833-9d1e-f9f4cdacd9f3	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	e0e80435-1b6a-4361-8c8a-e432f8f23a1b	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE HYCLATE	Cardinal Health 107, LLC	53deb73a-c828-46e8-994e-d84e3bf8dc98	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
DOXYCYCLINE DOXYCYCLINE	DOXYCYCLINE	Dr. Reddy's Laboratories, Inc.	c0206e91-d87f-311c-80dc-aad543d001e8	2025-10-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Solco Healthcare US,LLC	99305d9a-d058-45d6-8dec-19308b1fc5a9	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Chartwell Governmental & Specialty RX, LLC	b8486639-7eb9-4610-9cd4-0e922045d592	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Chartwell RX LLC	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Piramal Critical Care Inc	fd672959-014f-8300-e053-6394a90a5ec5	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE	Amneal Pharmaceuticals NY LLC	49ecbf95-58e8-4f3c-b5d5-650a15d866cb	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE	Amneal Pharmaceuticals NY LLC	79f3c026-7687-4a11-8d2e-03493531d3bf	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	AvKARE	3dd8c11c-aa52-9e22-e063-6294a90a5cbd	2025-09-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Proficient Rx LP	00ea3641-18da-4a6f-a779-e16075464d2b	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2bcde264-5f6f-47f6-ae2e-1b7010deacf7	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Alembic Pharmaceuticals Inc.	a50e953d-447b-4b66-b567-04586174d3f9	2025-06-16	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Macleods Pharmaceuticals Limited	10aca485-850b-4c82-bb7e-5fac2d7a62ce	2025-06-07	Warnings, Adverse reactions	Name fallback brand name: doxycycline 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