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 9 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	Redpharm Drug	0b251a58-30d8-dfec-e063-6294a90a3b45	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Direct_Rx	8c273efa-62ec-16b2-e053-2995a90ac41d	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	direct rx	b56dffde-1334-f5a0-e053-2a95a90a717c	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	American Health Packaging	adc6ba78-8dd7-47af-a7b4-c2215557696b	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline	DOXYCYCLINE	Mylan Institutional LLC	878a1cf9-31a9-425b-910d-042ed91e98d5	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	65b3a0e2-32a5-436a-b805-854fbffcb611	2025-01-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	19d93cd3-6ac6-4e5d-8e7e-1a48799df3cf	2025-01-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	7ce80f6e-3c0d-4978-b626-5fd3f3ff349e	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	b4f2ab4f-c32b-6435-e053-2995a90a69b6	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	ecab47ea-d7b9-515d-e053-2995a90adc46	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	f5ed9293-15f8-ecfa-e053-2a95a90ab6a4	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Quality Care Products, LLC	2a3b79e8-f14c-4b44-9d3e-3c92a82269bd	2024-12-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Amneal Pharmaceuticals LLC	95ba4d68-2519-4edd-b9a2-5cd2fd00b250	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Diirect_rx	1b403f4b-1c61-3991-e063-6394a90ae4f2	2024-12-02	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	2024-11-28		Name fallback brand name: doxycycline
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	bcc65910-30d8-4807-ab61-607a56382924	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	fd58dbe5-aab2-4378-b054-d5c60d87074e	2024-10-08	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NCS HealthCare of KY, LLC dba Vangard Labs	104cac0f-7c99-4faf-ba08-0159ed767a3e	2024-10-07	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	5f22094e-9297-4d1b-a37c-7846481b321e	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	30b041a0-8f5f-4d9f-b11b-106f7432955b	2024-08-23	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.