Application 200480

Type: ANDA
Sponsor: NOVOCOL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DYCLOPRO	DYCLONINE HYDROCHLORIDE	SOLUTION;TOPICAL	0.5%	No	Yes
002	DYCLOPRO	DYCLONINE HYDROCHLORIDE	SOLUTION;TOPICAL	1%	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A200480-001	DYCLOPRO	DYCLONINE HYDROCHLORIDE	0.5%	SOLUTION / TOPICAL		RS	2018-11-20
A200480-002	DYCLOPRO	DYCLONINE HYDROCHLORIDE	1%	SOLUTION / TOPICAL		RS	2018-11-20

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200480-001	DYCLOPRO	0.5%	SOLUTION / TOPICAL	RS	2018-11-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A200480-002	DYCLOPRO	1%	SOLUTION / TOPICAL	RS	2018-11-20	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DycloPro	DYCLONINE HYDROCHLORIDE	Septodont Inc	bfd9a2dd-7b40-40c0-b256-52f613395760	2024-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200480 application number: ANDA200480 ndc (product): 0362-3971

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0362-3918	DycloPro	Dyclonine Hydrochloride	Septodont Inc	ANDA	Current
0362-3971	DycloPro	Dyclonine Hydrochloride	Septodont Inc	ANDA	Current
0362-3971	DycloPro	Dyclonine Hydrochloride	Septodont Inc	ANDA	Current
0362-3971	DycloPro	Dyclonine Hydrochloride	Septodont Inc	ANDA	Current