Application 208263

Type: ANDA
Sponsor: NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208263-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL			2021-11-22
A208263-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL			2021-11-22

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 2 · 70 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	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		2021-11-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		2021-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-11-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-11-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208263-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-11-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208263-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-11-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A208263-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208263-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208263-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208263-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208263-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208263-002	AB	1	`782e0a99824c…`

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 7 of 8 · 145 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a5f02688-cbba-4d9b-e053-2995a90ad1ba	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a707c9e3-00eb-e832-e053-2a95a90a5f58	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a2161675-505c-3d65-e053-2995a90aa644	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	860a1566-5857-ed88-e053-2991aa0ae2a4	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	88012cf8-509b-84cf-e053-2a95a90af3bc	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	a2df1a8c-7a22-462d-830a-04e6ac5a912f	2024-04-28	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	1dd7a94e-bf29-4f07-9476-ac8d1f9ab565	2024-04-28	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	4164f6b7-5ebd-4f5f-a536-9a37b2e0562c	2024-04-28	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	a84d7562-08bf-417f-a599-ba0d17c55232	2024-04-25	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Proficient Rx LP	e38f3cd2-47e5-438f-bbe3-50b578360f74	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Lupin Pharmaceuticals,Inc.	b752ea66-3144-4f78-96fe-a5f4d92740a7	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0fdc3d87-8819-4c2c-e063-6394a90a687b	2024-01-26	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	e567b431-53fe-4e27-9b05-bf6eeb8abb51	2023-12-11	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2023-04-10	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	6e587d8d-1a82-4dfa-acea-88704d408f2f	2023-01-30	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	24c8472a-dd07-4f84-8bea-20a3f178d119	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	ec4535a1-69f0-40a2-bcba-11afc75c721d	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	dd7672c9-b10f-4ea1-9000-ef3e3faa10db	2022-09-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE	Proficient Rx LP	e2151005-fb4a-485d-88ad-b44c4594d579	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	86c1f165-af79-4f01-ab61-3bdbce24cd0d	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.