Application 062569

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	Yes
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
A062569-001	DOXYCYCLINE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09
A062569-002	DOXYCYCLINE	DOXYCYCLINE HYCLATE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062569-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-03-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062569-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION			1988-03-09	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062569-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062569-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062569-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062569-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062569-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062569-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062569-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062569-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062569-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062569-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062569-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062569-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062569-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062569-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062569-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062569-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062569-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062569-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062569-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062569-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062569-001	AP	1	`cb3db0bc1861…`

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 1 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	REMEDYREPACK INC.	051654c7-8ba6-44f2-842c-72f515e9b32d	2026-09-15	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	HAWAII REPACK, INC	88c429a1-351d-432e-b69b-d7a0afca482a	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9ecadbc8-3087-4692-916a-b7f392d8e8da	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	5fdc01c3-c62f-40cf-8351-91cbcc43d379	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	df44c686-de34-487a-8741-a0a12993cab2	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2c29f716-bdb0-437d-92a4-d856b87db976	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0106a3d3-db4d-f6ee-e063-6294a90a25e9	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline	DOXYCYCLINE	Coupler LLC	595470f9-2004-c378-e063-6294a90a3415	2026-08-18	Warnings, Adverse reactions	Name fallback brand name: doxycycline
Doxycycline	DOXYCYCLINE HYCLATE	Acella Pharmaceuticals, LLC	3fb9f5ad-90a2-4858-bc34-f800d8b2fa90	2026-08-18	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE	NuCare Pharmaceuticals,Inc.	2a07049d-3950-d293-e063-6294a90a4450	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	f0fbf63a-e75c-40cf-b2e9-429deaac899d	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: doxycycline
Doxycycline	DOXYCYCLINE	Avenacy Inc.	429813b4-0223-4d85-a844-b1227ff63b1e	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Major Pharmaceuticals	e7c14a8e-c713-4f03-94e8-1ec9ae077d4d	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2305ab4a-7d08-41f6-9c39-c9b6835be389	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
doxycycline	DOXYCYCLINE	A-S Medication Solutions	fe8cd3c6-36d6-4d92-bc5c-833cd6f9cb32	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: doxycycline
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	db53637e-16ac-41b0-b9d5-553471405d64	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	2946fc05-78e5-4669-85d1-3a3979eceae0	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Proficient Rx LP	d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	2026-08-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	bcc95094-80ed-4023-b2a6-955a4810bfbe	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: doxycycline
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c	2026-07-29	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.