Application 205115

Type: ANDA
Sponsor: ZYDUS PHARMS

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 75MG BASE	No	No
003	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 100MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205115-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18
A205115-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18
A205115-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205115-001	AB
A205115-002	AB
A205115-003	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 4 · 129 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	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`

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	A205115-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205115-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205115-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205115-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205115-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205115-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205115-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205115-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205115-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205115-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205115-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205115-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205115-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205115-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205115-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205115-001	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	Safecor Health, LLC	f02f5358-dd42-44d7-802d-a3001e0d4f13	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	Coupler LLC	595470f9-2004-c378-e063-6294a90a3415	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	PD-Rx Pharmaceuticals, Inc.	7028b7f9-21cd-4c8e-97aa-a3e7d849939b	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	PD-Rx Pharmaceuticals, Inc.	dedebcb4-3c3f-4487-a488-36af12640c92	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
DOXYCYCLINE	DOXYCYCLINE	DIRECT RX	31512ece-cb16-2a9a-e054-00144ff88e88	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115 ndc (product): 61919-624
doxycycline	DOXYCYCLINE	A-S Medication Solutions	2c7795c9-9e4e-477a-ad9f-01e4c55c06b6	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115 ndc (product): 50090-4833
doxycycline	DOXYCYCLINE	AvPAK	a5b28a41-db12-af7c-e053-2995a90ace09	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115 ndc (product): 50268-280 ndc (product): 50268-281
doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	fef9580d-8850-4cbb-89eb-2b4d40ee59c9	2025-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115 ndc (product): 68382-706 ndc (product): 68382-707 ndc (product): 68382-782
doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	2024-11-28		Exact identifier application applno (ANDA): 205115 application number: ANDA205115 ndc (product): 65841-821 ndc (product): 65841-822 ndc (product): 65841-823
doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	5f989cc1-48ae-41bb-b297-2f8c83760b6d	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115 ndc (product): 71335-1479
doxycycline	DOXYCYCLINE	Proficient Rx LP	f3ba6c30-ada3-4a57-9ff8-30558202b9aa	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115 ndc (product): 63187-712

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4833	doxycycline	doxycycline	A-S Medication Solutions	ANDA	Current
50090-4833	doxycycline	doxycycline	A-S Medication Solutions	ANDA	Current
50090-4833	doxycycline	doxycycline	A-S Medication Solutions	ANDA	Current
50090-4833	doxycycline	doxycycline	A-S Medication Solutions	ANDA	Current
50268-280	doxycycline	doxycycline	AvPAK	ANDA	Current
50268-280	doxycycline	doxycycline	AvPAK	ANDA	Current
50268-280	doxycycline	doxycycline	AvPAK	ANDA	Current
50268-281	doxycycline	doxycycline	AvPAK	ANDA	Current
50268-281	doxycycline	doxycycline	AvPAK	ANDA	Current
50268-281	doxycycline	doxycycline	AvPAK	ANDA	Current
55700-723	doxycycline	doxycycline	Quality Care Products, LLC	ANDA	Current
55700-723	doxycycline	doxycycline	Quality Care Products, LLC	ANDA	Current
55700-723	doxycycline	doxycycline	Quality Care Products, LLC	ANDA	Current
61919-624	DOXYCYCLINE MONOHYDRATE	DOXYCYCLINE MONOHYDRATE	DIRECT RX	ANDA	Current
61919-624	DOXYCYCLINE MONOHYDRATE	DOXYCYCLINE MONOHYDRATE	DIRECT RX	ANDA	Current
61919-624	DOXYCYCLINE MONOHYDRATE	DOXYCYCLINE MONOHYDRATE	DIRECT RX	ANDA	Current
63187-712	doxycycline	doxycycline	Proficient Rx LP	ANDA	Current
63187-712	doxycycline	doxycycline	Proficient Rx LP	ANDA	Current
65841-821	doxycycline	doxycycline	Cadila Healthcare Limited	ANDA	Current
65841-821	doxycycline	doxycycline	Zydus Lifesciences Limited	ANDA	Current
65841-821	doxycycline	doxycycline	Cadila Healthcare Limited	ANDA	Current
65841-821	doxycycline	doxycycline	Cadila Healthcare Limited	ANDA	Current
65841-822	doxycycline	doxycycline	Cadila Healthcare Limited	ANDA	Current
65841-822	doxycycline	doxycycline	Zydus Lifesciences Limited	ANDA	Current
65841-822	doxycycline	doxycycline	Cadila Healthcare Limited	ANDA	Current
65841-822	doxycycline	doxycycline	Cadila Healthcare Limited	ANDA	Current
65841-823	doxycycline	doxycycline	Cadila Healthcare Limited	ANDA	Current
65841-823	doxycycline	doxycycline	Zydus Lifesciences Limited	ANDA	Current
65841-823	doxycycline	doxycycline	Cadila Healthcare Limited	ANDA	Current
65841-823	doxycycline	doxycycline	Cadila Healthcare Limited	ANDA	Current
67296-1385	doxycycline	doxycycline	RedPharm Drug, Inc.	ANDA	Current
67296-1385	doxycycline	doxycycline	RedPharm Drug, Inc.	ANDA	Current
67296-1385	doxycycline	doxycycline	RedPharm Drug, Inc.	ANDA	Current
68382-706	doxycycline	doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-706	doxycycline	doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-706	doxycycline	doxycycline	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-706	doxycycline	doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-707	doxycycline	doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-707	doxycycline	doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-707	doxycycline	doxycycline	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-707	doxycycline	doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-782	doxycycline	doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-782	doxycycline	doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-782	doxycycline	doxycycline	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-782	doxycycline	doxycycline	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
71335-0436	doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current
71335-0436	doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current
71335-0436	doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current
71335-1479	doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current
71335-1479	doxycycline	doxycycline	Bryant Ranch Prepack	ANDA	Current