Application 200065

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 150MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200065-001	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL			2011-02-17

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	2011-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200065-001	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL		2011-02-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A200065-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200065-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200065-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200065-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200065-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200065-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200065-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200065-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200065-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200065-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200065-001	AB	1	`ea99ee380514…`

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 6 · 103 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	b0894010-39bd-459f-8563-cf83343105ee	2020-06-04	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Proficient Rx LP	f3ba6c30-ada3-4a57-9ff8-30558202b9aa	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Sun Pharmaceutical Industries Inc.	8224b9c5-5c4b-4dda-bc58-47b6604c2884	2018-08-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1327	Doxycycline	Doxycycline	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1327	Doxycycline	Doxycycline	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1327	Doxycycline	Doxycycline	Impax Generics	ANDA	Current