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 1.

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 · 123 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205115-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205115-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205115-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205115-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205115-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205115-001	AB	1	`8072bd15b7f6…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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