Application 065094

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No
002	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	TABLET;ORAL	300MG	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
A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL			2004-03-22
A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL			2004-03-22

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	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065094-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	2004-03-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065094-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	2004-03-22	`3a93d1ddd44b…`

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Demeclocycline Hydrochloride	DEMECLOCYCLINE	Amneal Pharmaceuticals of New York LLC	539add06-e0a0-401a-b4f6-20776084aa9c	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Demeclocycline Hydrochloride
Demeclocycline Hydrochloride	DEMECLOCYCLINE HYDROCHLORIDE	PuraCap Laboratories LLC	88e03cb0-25f5-41a5-b77f-58ab8f3be181	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Demeclocycline Hydrochloride generic name: DEMECLOCYCLINE HYDROCHLORIDE
Demeclocycline Hydrochloride	DEMECLOCYCLINE	Amneal Pharmaceuticals LLC	4ff23e3b-e111-47fd-9776-1d89d6da049b	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: Demeclocycline Hydrochloride
Demeclocycline Hydrochloride	DEMECLOCYCLINE	American Health Packaging	e6adaf70-5ff9-4395-bff1-0f332090cb80	2024-09-26	Warnings, Adverse reactions	Name fallback brand name: Demeclocycline Hydrochloride
Demeclocycline Hydrochloride	DEMECLOCYCLINE HYDROCHLORIDE	Epic Pharma, LLC	645af8f4-0843-4afb-9ddc-f587f38adb68	2023-11-08	Warnings, Adverse reactions	Name fallback brand name: Demeclocycline Hydrochloride generic name: DEMECLOCYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.