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 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
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.

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
2026-08-01 22:54:32	2026-06	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A091605-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091605-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091605-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091605-004	AB	1	`a50c72e98297…`

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 · 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