Application 207964

Type: NDA
Sponsor: MEDLINE INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	READYPREP CHG	CHLORHEXIDINE GLUCONATE	CLOTH;TOPICAL	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N207964-001	READYPREP CHG	CHLORHEXIDINE GLUCONATE	2%	CLOTH / TOPICAL		RLD, 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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL	RLD, RS	2018-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL	RLD, RS	2018-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207964-001	READYPREP CHG	2%	CLOTH / TOPICAL		2018-11-20	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N207964-001	NP	2021-11-20	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N207964-001	NP	2021-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207964-001	NP	2021-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207964-001	NP	2021-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207964-001	NP	2021-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207964-001	NP	2021-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207964-001	NP	2021-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207964-001	NP	2021-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207964-001	NP	2021-11-20	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ReadyPrep CHG	CHLORHEXIDINE GLUCONATE 2%	Medline Industries, LP	458cf999-5e3d-4d4d-82d5-02118c331893	2024-09-09	Warnings	Exact identifier application applno (NDA): 207964 application number: NDA207964 ndc (product): 53329-244

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53329-244	ReadyPrep CHG	Chlorhexidine gluconate 2%	Medline Industries	NDA	Current
53329-244	ReadyPrep CHG	Chlorhexidine gluconate 2%	Medline Industries	NDA	Current
53329-244	ReadyPrep CHG	Chlorhexidine gluconate 2%	Medline Industries, LP	NDA	Current
53329-244	ReadyPrep CHG	Chlorhexidine gluconate 2%	Medline Industries, LP	NDA	Current
53329-244	ReadyPrep CHG	Chlorhexidine gluconate 2%	Medline Industries, LP	NDA	Current
53329-244	ReadyPrep CHG	Chlorhexidine gluconate 2%	Medline Industries, LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74370	SUPPL	2023-05-25
74369	SUPPL	2023-05-25
58999	ORIG	2019-06-10
57114	ORIG	2019-01-31
56632	ORIG	2018-12-04