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 7 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Larken Laboratories, Inc.	49f82130-6f8a-412c-b625-e75906e74675	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2bcde264-5f6f-47f6-ae2e-1b7010deacf7	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	b612d2f5-b703-47f0-b5eb-b66a7aeed577	2025-06-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Actavis Pharma, Inc.	a569ba80-ffea-40b2-9fbe-a42810b1fccb	2025-06-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	294c6fc3-e7ca-46ea-b062-a27dd7b0bc97	2025-06-20	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	6772807d-a39e-47ce-9584-a08e7f8940d2	2025-06-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE	DOXYCYCLINE	Alembic Pharmaceuticals Inc.	a50e953d-447b-4b66-b567-04586174d3f9	2025-06-16	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Macleods Pharmaceuticals Limited	10aca485-850b-4c82-bb7e-5fac2d7a62ce	2025-06-07	Warnings, Adverse reactions	Name fallback brand name: doxycycline
Doxycycline	DOXYCYCLINE	Dr.Reddys Laboratories Inc	7a28cce1-4805-b3d1-4484-e7a49c597660	2025-06-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	81c5a7fc-3fe0-40b2-bae0-c79eb0b27697	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	b46208a2-5072-4df5-b2af-379f865545d2	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	bed39bae-64c2-44b4-9c95-682ead4e6738	2025-05-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	a5571acf-3284-4559-8cc0-b4856ac6d94d	2025-05-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	2b3b3c48-eb60-400c-bdfe-50635a136c90	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	61195fc6-3fa7-4203-b526-477b48395856	2025-05-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9cbd8699-e2c2-40d4-8797-e676f2a10eb2	2025-05-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	7c33c1b8-100e-4df8-be8d-de3eed7ced94	2025-04-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	fef9580d-8850-4cbb-89eb-2b4d40ee59c9	2025-04-26	Warnings, Adverse reactions	Name fallback brand name: doxycycline
Doxycycline	DOXYCYCLINE	Sun Pharmaceutical Industries, Inc.	829dbd3d-5c2b-47b8-96a5-423af78c93b9	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	cec4368f-2852-443d-9d6f-7ba95807021b	2025-04-16	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.