Application 090431

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 75MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 100MG BASE	No	No
003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 50MG BASE	No	No
004	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 80MG BASE	No	No
005	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 200MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090431-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28
A090431-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28
A090431-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23
A090431-004	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29
A090431-005	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090431-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090431-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090431-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090431-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090431-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090431-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090431-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090431-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090431-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090431-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090431-005	AB	1	`ea99ee380514…`

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 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2c29f716-bdb0-437d-92a4-d856b87db976	2026-08-06	Warnings, Adverse reactions	Name fallback 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
doxycycline hyclate	DOXYCYCLINE HYCLATE	Slate Run Pharmaceuticals, LLC	f31e69fc-e513-40e4-91b5-22ccf1ed9437	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	Acella Pharmaceuticals, LLC	3fb9f5ad-90a2-4858-bc34-f800d8b2fa90	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Unit Dose Solutions, Inc.	548d4218-2feb-8716-e063-6394a90afbe3	2026-06-18	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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4531	Doxycycline Hyclate	doxycycline hyclate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4532	Doxycycline Hyclate	doxycycline hyclate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4533	Doxycycline Hyclate	doxycycline hyclate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4535	Doxycycline Hyclate	doxycycline hyclate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4535	Doxycycline Hyclate	doxycycline hyclate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4535	Doxycycline Hyclate	doxycycline hyclate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4535	Doxycycline Hyclate	doxycycline hyclate	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31466	SUPPL	2016-05-27
39609	SUPPL	2016-05-26
31467	SUPPL	2016-05-25
9268	SUPPL	2016-05-04
18535	SUPPL	2016-05-03