Application 062450

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE	DOXYCYCLINE HYCLATE	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	No	No
002	DOXYCYCLINE	DOXYCYCLINE HYCLATE	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A062450-001	DOXYCYCLINE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION			1983-10-27
A062450-002	DOXYCYCLINE	DOXYCYCLINE HYCLATE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1983-10-27

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062450-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062450-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	1983-10-27	`4b0b4de00fa7…`

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 2 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Wellhouse Pharma, LLC	57f97f68-11fb-4900-9efb-ca3b00818d8e	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	3af9348c-a98b-4059-a5ef-4229e2b33af0	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	0994d23a-f9e4-4c33-ba44-a1f4ae4a312c	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	1401d590-0967-4c6b-b52b-a83e9f6df097	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	b988f851-cc06-4570-9706-cf65d370bd8e	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	35aa295e-ff1b-453b-8eeb-65bbeda3baa5	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	04de98f3-33a2-48ba-85b5-9fac867524b7	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycyclate Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Golden State Medical Supply, Inc.	e9997efa-9ad8-3870-e053-2a95a90a1ac3	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	6e3d0691-c071-441c-9b00-22a380305066	2026-07-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	fad03768-f1d2-459f-965e-0ec29f189f1f	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Strides Pharma Science Limited	2deeee4f-b342-a178-e063-6394a90af897	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Strides Pharma Science Limited	b8b76aaa-575b-497f-b854-c42bc992c784	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	St. Mary's Medical Park Pharmacy	02f87c60-8425-1a1e-e063-6294a90a0c94	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE	DOXYCYCLINE	REMEDYREPACK INC.	fa2d9328-b688-47af-8c4d-dc328cf35392	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Slate Run Pharmaceuticals, LLC	f31e69fc-e513-40e4-91b5-22ccf1ed9437	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Unit Dose Solutions, Inc.	548d4218-2feb-8716-e063-6394a90afbe3	2026-06-18	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	9e710113-f25e-46fb-8327-7a8e649613a2	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	e24a3292-0d4f-4692-8cf7-a82bd19e5932	2026-06-08	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE

Reported adverse events (FAERS/openFDA)#

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