Application 065285

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 100MG BASE	No	No
003	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 75MG BASE	No	No
004	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 150MG 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065285-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08
A065285-002	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08
A065285-003	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30
A065285-004	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065285-001	AB
A065285-002	AB
A065285-003	AB
A065285-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065285-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2005-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065285-002	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2005-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065285-003	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2008-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065285-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2008-07-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A065285-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065285-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065285-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065285-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065285-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065285-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065285-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065285-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065285-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065285-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065285-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065285-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065285-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065285-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065285-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065285-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065285-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065285-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065285-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065285-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065285-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065285-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065285-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065285-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065285-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065285-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065285-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065285-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065285-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065285-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065285-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065285-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065285-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065285-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065285-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065285-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065285-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065285-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065285-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065285-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	American Health Packaging	adc6ba78-8dd7-47af-a7b4-c2215557696b	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065285 application number: ANDA065285 ndc (product): 60687-344
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	5f22094e-9297-4d1b-a37c-7846481b321e	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065285 application number: ANDA065285
Doxycycline	DOXYCYCLINE	Lannett Company, Inc.	4999bbd9-44ed-4749-9730-be2337bdf490	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065285 application number: ANDA065285 ndc (product): 0527-1335 ndc (product): 0527-1537 ndc (product): 0527-1535 ndc (product): 0527-1338

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-0129	Doxycycline	Doxycycline	KAISER FOUNDATION HOSPITALS	ANDA	Current
0527-1335	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1335	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1335	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1335	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1335	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1338	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1338	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1338	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1338	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1338	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1535	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1535	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1535	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1535	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1535	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1537	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1537	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1537	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1537	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
0527-1537	Doxycycline	Doxycycline	Lannett Company, Inc.	ANDA	Current
42291-156	Doxycycline	Doxycycline	AvKARE, Inc.	ANDA	Current
42291-156	Doxycycline	Doxycycline	AvKARE, Inc.	ANDA	Current
42291-156	Doxycycline	Doxycycline	AvKARE	ANDA	Current
42783-601	Doxycycline	Doxycycline	Elorac, Inc.	ANDA	Current
42783-601	Doxycycline	Doxycycline	Elorac, Inc.	ANDA	Current
50090-1787	Doxycycline	Doxycycline	A-S Medication Solutions	ANDA	Current
60687-344	Doxycycline	Doxycycline	American Health Packaging	ANDA	Current
60687-344	Doxycycline	Doxycycline	American Health Packaging	ANDA	Current
60687-344	Doxycycline	Doxycycline	American Health Packaging	ANDA	Current
60687-344	Doxycycline	Doxycycline	American Health Packaging	ANDA	Current
61919-299	DOXYCYCLINE	DOXYCYCLINE	DirectRX	ANDA	Current
70934-808	Doxycycline	Doxycycline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-2109	Doxycycline	Doxycycline	Bryant Ranch Prepack	ANDA	Current