Application 065055

Type: ANDA
Sponsor: PAR PHARM

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065055-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01
A065055-002	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01
A065055-003	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15
A065055-004	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065055-001	AB
A065055-002	AB
A065055-003	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 · 172 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
2026-09-14 22:38:34	2026-08	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065055-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065055-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065055-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065055-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065055-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065055-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065055-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065055-001	AB	1	`301d65b070ca…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	04de98f3-33a2-48ba-85b5-9fac867524b7	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	Golden State Medical Supply, Inc.	e9997efa-9ad8-3870-e053-2a95a90a1ac3	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055 ndc (product): 51407-678
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	9e710113-f25e-46fb-8327-7a8e649613a2	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055 ndc (product): 64380-180 ndc (product): 64380-179 ndc (product): 64380-181
Doxycycline	DOXYCYCLINE	American Health Packaging	e49f8ff9-af7a-47eb-929b-238cff381c03	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	American Health Packaging	3fbf4bb8-036e-41d3-9628-476fc05ddd31	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055 ndc (product): 60687-716
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	6285181d-e34d-4def-abe6-2c41254ada75	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	NuCare Pharmaceuticals,Inc.	fa1da527-7a0f-8ed6-e053-6394a90a1b62	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	Proficient Rx LP	c707566b-dbc7-4dac-bad1-952f2f4d6845	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	6aab6fee-791e-4141-b55f-685ec9d8712a	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10337-815	Adoxa	doxycycline	PharmaDerm a division of Fougera Pharmaceuticals Inc.	ANDA	Current
49884-305	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-305	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-305	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-305	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-726	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-726	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-726	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-726	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-727	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-727	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-727	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
49884-727	Doxycycline	doxycycline	Par Pharmaceutical, Inc.	ANDA	Current
50090-1472	Doxycycline	doxycycline	A-S Medication Solutions	ANDA	Current
50090-1472	Doxycycline	doxycycline	A-S Medication Solutions	ANDA	Current
50090-1472	Doxycycline	doxycycline	A-S Medication Solutions	ANDA	Current
51407-387	Doxycycline	doxycycline	Golden State Medical Supply	ANDA	Current
51407-387	Doxycycline	doxycycline	Golden State Medical Supply	ANDA	Current
51407-387	Doxycycline	doxycycline	Golden State Medical Supply, Inc.	ANDA	Current
51407-387	Doxycycline	doxycycline	Golden State Medical Supply, Inc.	ANDA	Current
51407-678	Doxycycline	doxycycline	Golden State Medical Supply, Inc.	ANDA	Current
55700-323	Doxycycline	doxycycline	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60687-716	Doxycycline	Doxycycline	American Health Packaging	ANDA	Current
63187-135	Doxycycline	doxycycline	Proficient Rx LP	ANDA	Current
63187-135	Doxycycline	doxycycline	Proficient Rx LP	ANDA	Current
63629-2183	Doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current
63629-2183	Doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current
63629-6637	Doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current
63629-8212	Doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current
63629-8212	Doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current
64380-179	Doxycycline	doxycycline	Strides Pharma Science Limited	ANDA	Current
64380-180	Doxycycline	doxycycline	Strides Pharma Science Limited	ANDA	Current
64380-181	Doxycycline	doxycycline	Strides Pharma Science Limited	ANDA	Current
67296-1025	Doxycycline	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
67296-1025	Doxycycline	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
68084-743	Doxycycline	Doxycycline	American Health Packaging	ANDA	Current
68084-743	Doxycycline	Doxycycline	American Health Packaging	ANDA	Current
68084-743	Doxycycline	Doxycycline	American Health Packaging	ANDA	Current
68084-743	Doxycycline	Doxycycline	American Health Packaging	ANDA	Current
70518-0187	Doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-0187	Doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-0187	Doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-0187	Doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-0187	Doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-0187	Doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-0221	Doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-0221	Doxycycline	doxycycline	REMEDYREPACK INC.	ANDA	Current
76519-1206	DOXYCYCLINE	DOXYCYCLINE	H.J. Harkins Company, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18325	SUPPL	2014-07-30
30641	SUPPL	2014-07-24
18324	SUPPL	2014-02-06
30640	ORIG	2000-12-01