Application 208765

Type: ANDA
Sponsor: MAYNE PHARMA INC

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 42.

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
A208765-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB		2017-06-14
A208765-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB		2017-06-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208765-001	AB
A208765-002	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 3 · 84 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	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208765-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-06-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208765-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-06-14	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A208765-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208765-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208765-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208765-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208765-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208765-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208765-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208765-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208765-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208765-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208765-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208765-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208765-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208765-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208765-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208765-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208765-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208765-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208765-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208765-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208765-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208765-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208765-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208765-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208765-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208765-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208765-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208765-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208765-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208765-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208765-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208765-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208765-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208765-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208765-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208765-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208765-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208765-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208765-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208765-002	AB	1	`bb7c543d1eb4…`

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 8 · 146 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0106a3d3-db4d-f6ee-e063-6294a90a25e9	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	5fdc01c3-c62f-40cf-8351-91cbcc43d379	2026-08-18	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	Acella Pharmaceuticals, LLC	3fb9f5ad-90a2-4858-bc34-f800d8b2fa90	2026-08-18	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Major Pharmaceuticals	e7c14a8e-c713-4f03-94e8-1ec9ae077d4d	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2305ab4a-7d08-41f6-9c39-c9b6835be389	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	c8194d6e-c407-465e-a342-4d2d9756dfc4	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	db53637e-16ac-41b0-b9d5-553471405d64	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	3af9348c-a98b-4059-a5ef-4229e2b33af0	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	0994d23a-f9e4-4c33-ba44-a1f4ae4a312c	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	1401d590-0967-4c6b-b52b-a83e9f6df097	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	b988f851-cc06-4570-9706-cf65d370bd8e	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	35aa295e-ff1b-453b-8eeb-65bbeda3baa5	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	HAWAII REPACK, INC	88c429a1-351d-432e-b69b-d7a0afca482a	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycyclate Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	6e3d0691-c071-441c-9b00-22a380305066	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	fad03768-f1d2-459f-965e-0ec29f189f1f	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Strides Pharma Science Limited	2deeee4f-b342-a178-e063-6394a90af897	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Strides Pharma Science Limited	b8b76aaa-575b-497f-b854-c42bc992c784	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	St. Mary's Medical Park Pharmacy	02f87c60-8425-1a1e-e063-6294a90a0c94	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-695	Doxycycline Hyclate	Doxycycline Hyclate	Mayne Pharma Inc.	ANDA	Current
51862-695	Doxycycline Hyclate	Doxycycline Hyclate	Mayne Pharma Inc.	ANDA	Current
51862-695	Doxycycline Hyclate	Doxycycline Hyclate	Mayne Pharma Inc.	ANDA	Current
51862-696	Doxycycline Hyclate	Doxycycline Hyclate	Mayne Pharma Inc.	ANDA	Current
51862-696	Doxycycline Hyclate	Doxycycline Hyclate	Mayne Pharma Inc.	ANDA	Current
51862-696	Doxycycline Hyclate	Doxycycline Hyclate	Mayne Pharma Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48721	ORIG	2017-06-15