Application 050261

Type: NDA
Sponsor: COREPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DECLOMYCIN	DEMECLOCYCLINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
002	DECLOMYCIN	DEMECLOCYCLINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No
003	DECLOMYCIN	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N050261-001	DECLOMYCIN	DEMECLOCYCLINE HYDROCHLORIDE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
N050261-002	DECLOMYCIN	DEMECLOCYCLINE HYDROCHLORIDE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
N050261-003	DECLOMYCIN	DEMECLOCYCLINE HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N050261-003	DECLOMYCIN	300MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050261-001	DECLOMYCIN	75MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050261-002	DECLOMYCIN	150MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050261-003	DECLOMYCIN	300MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050261-001	DECLOMYCIN	75MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050261-002	DECLOMYCIN	150MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050261-003	DECLOMYCIN	300MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050261-001	DECLOMYCIN	75MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050261-002	DECLOMYCIN	150MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050261-003	DECLOMYCIN	300MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050261-001	DECLOMYCIN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050261-002	DECLOMYCIN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050261-003	DECLOMYCIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Demeclocycline Hydrochloride	DEMECLOCYCLINE HYDROCHLORIDE	PuraCap Laboratories LLC	88e03cb0-25f5-41a5-b77f-58ab8f3be181	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: DEMECLOCYCLINE HYDROCHLORIDE
Demeclocycline Hydrochloride	DEMECLOCYCLINE HYDROCHLORIDE	Epic Pharma, LLC	645af8f4-0843-4afb-9ddc-f587f38adb68	2023-11-08	Warnings, Adverse reactions	Name fallback generic name: DEMECLOCYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7721	SUPPL	2012-09-07
17814	SUPPL	2012-09-06
17813	SUPPL	2008-06-05
29998	SUPPL	2008-04-25
7720	SUPPL	2003-12-22
7718	SUPPL	2003-12-22
7719	SUPPL	2003-05-30