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 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	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 · 172 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
2026-09-14 22:38:34	2026-08	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A209582-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209582-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209582-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209582-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209582-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209582-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209582-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209582-004	AB	1	`caaa826d4ba7…`
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…`

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 · 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