Application 091605

Type: ANDA
Sponsor: HERITAGE PHARMS 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 75MG BASE	No	No
003	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 100MG BASE	No	No
004	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 150MG BASE	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091605-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20
A091605-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20
A091605-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20
A091605-004	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091605-001	AB
A091605-002	AB
A091605-003	AB
A091605-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091605-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091605-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091605-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091605-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091605-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091605-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-004	AB	1	`d8e5a09893c0…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Proficient Rx LP	112c35d6-a397-45de-a57a-6e687cb27b4f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605
Doxycycline	DOXYCYCLINE	Northwind Health Company, LLC	f2f1ee15-9323-1263-e053-2995a90a01fa	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605
Doxycycline	DOXYCYCLINE	Chartwell RX, LLC	5bebf320-1395-43b9-9404-fe479d70b240	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605
Doxycycline	DOXYCYCLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2bcde264-5f6f-47f6-ae2e-1b7010deacf7	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605 ndc (product): 23155-136 ndc (product): 23155-135 ndc (product): 23155-134 ndc (product): 23155-133
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	2b3b3c48-eb60-400c-bdfe-50635a136c90	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605 ndc (product): 50090-1462

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-133	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-133	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-133	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-133	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-134	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-134	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-134	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-134	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-135	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-135	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-135	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-135	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-136	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-136	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-136	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-136	Doxycycline	Doxycycline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
50090-1462	Doxycycline	Doxycycline	A-S Medication Solutions	ANDA	Current
50090-1462	Doxycycline	Doxycycline	A-S Medication Solutions	ANDA	Current
55700-086	Doxycycline	Doxycycline	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-086	Doxycycline	Doxycycline	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-122	Doxycycline	Doxycycline	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-122	Doxycycline	Doxycycline	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-122	Doxycycline	Doxycycline	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-474	Doxycycline	Doxycycline	Direct Rx	ANDA	Current
61919-474	Doxycycline	Doxycycline	Direct Rx	ANDA	Current
70518-0038	Doxycycline	Doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-0038	Doxycycline	Doxycycline	REMEDYREPACK INC.	ANDA	Current
70518-0038	Doxycycline	Doxycycline	REMEDYREPACK INC.	ANDA	Current