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 44.

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 2 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090431-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090431-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2010-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090431-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090431-004	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090431-005	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	2016-05-19	`1e350fbaab3a…`

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 · 144 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	051654c7-8ba6-44f2-842c-72f515e9b32d	2026-09-15	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	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9ecadbc8-3087-4692-916a-b7f392d8e8da	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	5fdc01c3-c62f-40cf-8351-91cbcc43d379	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	df44c686-de34-487a-8741-a0a12993cab2	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2c29f716-bdb0-437d-92a4-d856b87db976	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0106a3d3-db4d-f6ee-e063-6294a90a25e9	2026-08-26	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	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
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

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 · 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