Application 074522

Type: ANDA
Sponsor: PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	SOLUTION;DENTAL	0.12%	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
A074522-001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT		1995-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A074522-001	AT

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	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074522-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	1995-12-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074522-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074522-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074522-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074522-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074522-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074522-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074522-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074522-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074522-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074522-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074522-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074522-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074522-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074522-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074522-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074522-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074522-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074522-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074522-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074522-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074522-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074522-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074522-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074522-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074522-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074522-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074522-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074522-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074522-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074522-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074522-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074522-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074522-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074522-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074522-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074522-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074522-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074522-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074522-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074522-001	AT	1	`e64feba35796…`

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
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	PAI Holdings, LLC dba PAI Pharma	d3c2d8a7-bad5-410f-af83-e78a45e4b93f	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074522 application number: ANDA074522 ndc (product): 0121-0893

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0893	Chlorhexidine	Chlorhexidine Gluconate	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0893	Chlorhexidine	Chlorhexidine Gluconate	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0893	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0893	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0893	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Pharmaceutical Associates, Inc.	ANDA	Current
68071-2377	Chlorhexidine	Chlorhexidine Gluconate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8173	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	Preferred Pharmaceuticals Inc.	ANDA	Current
81646-102	Chlorhexidine	Chlorhexidine Gluconate	PINNACLE PHARMA LLC	ANDA	Current