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 6 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	Cranbury Pharmaceuticals, LLC	43ceb0ee-268a-424c-a6a8-88e824c5ed04	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: doxycycline
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	0a18d4c7-9484-4d3e-b61b-e81fe63fefec	2025-10-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6624a43a-28ff-4d55-b5dd-1e805bfa8778	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Hikma Pharmaceuticals USA Inc.	4ec4c8ca-ce83-4948-8626-21eb82ae5c19	2025-10-28	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE	DOXYCYCLINE	Henry Schein, Inc	dd70368b-1949-4833-9d1e-f9f4cdacd9f3	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	e0e80435-1b6a-4361-8c8a-e432f8f23a1b	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
TARGADOX	DOXYCYCLINE HYCLATE	Journey Medical Corporation	83243f78-b984-46a4-a88a-c6a15c217b90	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	Cardinal Health 107, LLC	53deb73a-c828-46e8-994e-d84e3bf8dc98	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Ajanta Pharma USA Inc.	f18daceb-33a3-4931-9be7-ecd6356cc119	2025-10-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Solco Healthcare US,LLC	99305d9a-d058-45d6-8dec-19308b1fc5a9	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
doxycycline	DOXYCYCLINE	Chartwell Governmental & Specialty RX, LLC	b8486639-7eb9-4610-9cd4-0e922045d592	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE	DOXYCYCLINE	Piramal Critical Care Inc	fd672959-014f-8300-e053-6394a90a5ec5	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline	DOXYCYCLINE	AvKARE	3dd8c11c-aa52-9e22-e063-6294a90a5cbd	2025-09-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
DOXYCYCLINE	DOXYCYCLINE	Proficient Rx LP	00ea3641-18da-4a6f-a779-e16075464d2b	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Viona Pharmaceuticals Inc	51d245a3-ef51-474a-bc91-377d5f42dde3	2025-08-25	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	131af052-0c4f-4a61-ae9a-e6165ae09076	2025-08-19	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Hikma Pharmaceuticals USA Inc.	9b52e0a7-f024-4d8a-a59e-374946e60b44	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Viona Pharmaceuticals Inc	763997f0-b35c-43cb-a792-3e0bae589536	2025-08-12	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	JG Pharma Inc.	10b8bf71-4311-41e8-a891-bab8bc86863f	2025-08-01	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.