Application 209582

Type: ANDA
Sponsor: ZYDUS PHARMS

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	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
A209582-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28
A209582-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28
A209582-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28
A209582-004	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209582-001	AB
A209582-002	AB
A209582-003	AB
A209582-004	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	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`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	A209582-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209582-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209582-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209582-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209582-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209582-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209582-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209582-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209582-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209582-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209582-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209582-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209582-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209582-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209582-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209582-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209582-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209582-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209582-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209582-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209582-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209582-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209582-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209582-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209582-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209582-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209582-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209582-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209582-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209582-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209582-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209582-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209582-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209582-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209582-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209582-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209582-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209582-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209582-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209582-004	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	55873d3e-09c4-4726-acfe-5da581589575	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582 ndc (product): 50090-3809
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	b46208a2-5072-4df5-b2af-379f865545d2	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582
Doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	bc321932-b600-4659-a499-1853991b4ab9	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582 ndc (product): 70710-1121 ndc (product): 70710-1122 ndc (product): 70710-1124 ndc (product): 70710-1123
Doxycycline Monohydrate	DOXYCYCLINE MONOHYDRATE	Advanced Rx Pharmacy of Tennessee, LLC	f91373f2-c57b-f1f1-e053-6294a90a7bdd	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582
Doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	c886b2e4-494a-4325-abaf-981fc3d01c66	2024-11-28		Exact identifier application applno (ANDA): 209582 application number: ANDA209582 ndc (product): 70771-1009 ndc (product): 70771-1007 ndc (product): 70771-1008 ndc (product): 70771-1006
Doxycycline	DOXYCYCLINE	Proficient Rx LP	b83c4c4b-2885-43e7-b1c9-0b3bbf75528d	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582

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
50090-3809	Doxycycline	Doxycycline	A-S Medication Solutions	ANDA	Current
50090-3809	Doxycycline	Doxycycline	A-S Medication Solutions	ANDA	Current
67296-1740	Doxycycline	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
67296-1740	Doxycycline	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
67296-1740	Doxycycline	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
70710-1121	Doxycycline	Doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1121	Doxycycline	Doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1121	Doxycycline	Doxycycline	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1122	Doxycycline	Doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1122	Doxycycline	Doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1122	Doxycycline	Doxycycline	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1123	Doxycycline	Doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1123	Doxycycline	Doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1123	Doxycycline	Doxycycline	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1124	Doxycycline	Doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1124	Doxycycline	Doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1124	Doxycycline	Doxycycline	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1006	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1006	Doxycycline	Doxycycline	Zydus Lifesciences Limited	ANDA	Current
70771-1006	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1006	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1007	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1007	Doxycycline	Doxycycline	Zydus Lifesciences Limited	ANDA	Current
70771-1007	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1007	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1008	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1008	Doxycycline	Doxycycline	Zydus Lifesciences Limited	ANDA	Current
70771-1008	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1008	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1009	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1009	Doxycycline	Doxycycline	Zydus Lifesciences Limited	ANDA	Current
70771-1009	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70771-1009	Doxycycline	Doxycycline	Cadila Healthcare Limited	ANDA	Current
70934-325	Doxycycline	Doxycycline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-325	Doxycycline	Doxycycline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current