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 4 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	American Health Packaging	10988250-b267-4f10-b264-5f127cc1ae18	2026-02-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	American Health Packaging	3fbf4bb8-036e-41d3-9628-476fc05ddd31	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
DORYX MPC	DOXYCYCLINE HYCLATE	Mayne Pharma Commercial LLC	f9277bb8-982d-444d-9325-35d5c53a2d35	2026-02-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline	DOXYCYCLINE	A-S Medication Solutions	1c998ca8-1df6-4b3c-9533-f4500cc1079a	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: doxycycline
doxycycline	DOXYCYCLINE	A-S Medication Solutions	2c7795c9-9e4e-477a-ad9f-01e4c55c06b6	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: doxycycline
Doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	bea36ec9-f7fd-4295-bfbd-0228cffcddd7	2026-02-08	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Sportpharm LLC	45c4b584-b7e2-4e91-a93d-aff14feb606f	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	6285181d-e34d-4def-abe6-2c41254ada75	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
doxycycline hyclate	DOXYCYCLINE HYCLATE	Sportpharm LLC	50617adc-8528-414d-bb6c-78887d404983	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6e06e73c-b777-4a2d-988f-b009f2fc34d1	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	b70a3a12-76a2-4558-bf2c-eaa38a9ba0a0	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE	DOXYCYCLINE	JVET PHARMACEUTICALS LLC	ed95709e-2a1a-4deb-88bd-5b99f02b7a26	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	6f530f28-8c10-41dc-818f-1aef2306bde5	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	RedPharm Drug, Inc.	bdacaaa7-b46e-ee0c-e053-2a95a90aea3c	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Zhejiang Yongtai Pharmaceutical Co., Ltd	ccf9708a-ed3b-4786-b3a6-e96125b2f9d5	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE	DOXYCYCLINE	Par Health USA, LLC	acb84610-5e26-4b0c-89e5-42bc0f8fa00d	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	AiPing Pharmaceutical, Inc.	a894f4be-19e5-4785-8d0b-5e0d5626300e	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	AvPAK	a5b28a41-db12-af7c-e053-2995a90ace09	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: doxycycline
Doxycycline	DOXYCYCLINE	Proficient Rx LP	112c35d6-a397-45de-a57a-6e687cb27b4f	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Northwind Health Company, LLC	f7f6dc0d-cf8f-50b5-e053-6294a90a9e59	2026-01-01	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.