Application 050641

Type: NDA
Sponsor: ALMIRALL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONODOX	DOXYCYCLINE	CAPSULE;ORAL	EQ 100MG BASE	Yes	No
002	MONODOX	DOXYCYCLINE	CAPSULE;ORAL	EQ 50MG BASE	Yes	No
003	MONODOX	DOXYCYCLINE	CAPSULE;ORAL	EQ 75MG BASE	Yes	No
004	MONODOX	DOXYCYCLINE	CAPSULE;ORAL	EQ 150MG BASE	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050641-001	MONODOX	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29
N050641-002	MONODOX	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10
N050641-003	MONODOX	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18
N050641-004	MONODOX	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N050641-001	AB
N050641-002	AB
N050641-003	AB
N050641-004	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 · 154 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050641-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050641-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050641-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-004	AB	1	`d06236e962d9…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Wellhouse Pharma, LLC	57f97f68-11fb-4900-9efb-ca3b00818d8e	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050641 application number: NDA050641
Doxycycline Monohydrate	DOXYCYCLINE MONOHYDRATE	Chartwell RX, LLC.	02aa8731-d40f-43d8-8b63-a79a0503f8db	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050641 application number: NDA050641 ndc (product): 62135-260 ndc (product): 62135-263 ndc (product): 62135-262 ndc (product): 62135-261

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-0410	Doxycycline Monohydrate	Doxycycline	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-0410	Doxycycline Monohydrate	Doxycycline	Actavis Pharma, Inc.	NDA AUTHORIZED	Current
0591-0411	Doxycycline Monohydrate	Doxycycline	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-0411	Doxycycline Monohydrate	Doxycycline	Actavis Pharma, Inc.	NDA AUTHORIZED	Current
0591-2404	Doxycycline Monohydrate	Doxycycline	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2404	Doxycycline Monohydrate	Doxycycline	Actavis Pharma, Inc.	NDA AUTHORIZED	Current
16110-075	Monodox	doxycycline	Aqua Pharmaceuticals, LLC	NDA	Current
16110-259	Monodox	doxycycline	Aqua Pharmaceuticals, LLC	NDA	Current
16110-260	Monodox	doxycycline	Aqua Pharmaceuticals, LLC	NDA	Current
43063-529	Doxycycline Monohydrate	Doxycycline	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
43063-789	Doxycycline Monohydrate	Doxycycline	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
43063-789	Doxycycline Monohydrate	Doxycycline	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
53002-0671	Doxycycline Monohydrate	Doxycycline	RPK Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62135-260	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-260	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-260	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-260	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-260	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-261	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-261	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-261	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-261	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-261	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-262	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-262	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-262	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-262	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-262	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-263	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-263	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
62135-263	Doxycycline Monohydrate	Doxycycline Monohydrate	Chartwell RX, LLC.	NDA	Current
63629-5361	Doxycycline Monohydrate	Doxycycline	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
67296-1578	Doxycycline Monohydrate	Doxycycline Monohydrate	RedPharm Drug, Inc.	NDA	Current
67296-1578	Doxycycline Monohydrate	Doxycycline Monohydrate	RedPharm Drug, Inc.	NDA	Current
71610-220	Doxycycline Monohydrate	Doxycycline	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81852	SUPPL	2025-04-08
81794	SUPPL	2025-04-02
78451	SUPPL	2024-05-14
78444	SUPPL	2024-05-09
70202	SUPPL	2022-02-22
70190	SUPPL	2022-02-18
47870	SUPPL	2017-04-05
47852	SUPPL	2017-04-04
17969	SUPPL	2013-10-17
7926	SUPPL	2013-10-15
39067	SUPPL	2012-01-23
30216	SUPPL	2012-01-17
17968	SUPPL	2011-03-11
7925	SUPPL	2011-03-10
30215	SUPPL	2008-01-09
17967	SUPPL	2008-01-08
7924	SUPPL	2007-02-12
30214	SUPPL	2002-06-18
30213	SUPPL	2002-03-21