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 42.

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 · 126 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
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209396-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209396-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209396-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2017-09-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209396-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209396-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209396-001	AB	1	`1e350fbaab3a…`

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 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	Coupler LLC	595470f9-2004-c378-e063-6294a90a3415	2026-08-18	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE HYCLATE	Acella Pharmaceuticals, LLC	3fb9f5ad-90a2-4858-bc34-f800d8b2fa90	2026-08-18	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline	DOXYCYCLINE	NuCare Pharmaceuticals,Inc.	2a07049d-3950-d293-e063-6294a90a4450	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	f0fbf63a-e75c-40cf-b2e9-429deaac899d	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Avenacy Inc.	429813b4-0223-4d85-a844-b1227ff63b1e	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	A-S Medication Solutions	fe8cd3c6-36d6-4d92-bc5c-833cd6f9cb32	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	db53637e-16ac-41b0-b9d5-553471405d64	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	2946fc05-78e5-4669-85d1-3a3979eceae0	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	bcc95094-80ed-4023-b2a6-955a4810bfbe	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Wellhouse Pharma, LLC	57f97f68-11fb-4900-9efb-ca3b00818d8e	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	04de98f3-33a2-48ba-85b5-9fac867524b7	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Golden State Medical Supply, Inc.	e9997efa-9ad8-3870-e053-2a95a90a1ac3	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	REMEDYREPACK INC.	fa2d9328-b688-47af-8c4d-dc328cf35392	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	9e710113-f25e-46fb-8327-7a8e649613a2	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	55873d3e-09c4-4726-acfe-5da581589575	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	d3c0b756-30ba-4ef9-a178-fd785d720373	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	ST. MARY'S MEDICAL PARK PHARMACY	00b2aa98-dea2-90c3-e063-6294a90a35d6	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	American Health Packaging	e49f8ff9-af7a-47eb-929b-238cff381c03	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	7f882f1a-fe75-4592-9df5-f0e4bf1d232e	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE

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