Application 020310

Type: NDA
Sponsor: KRAMER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIZORAL A-D	KETOCONAZOLE	SHAMPOO;TOPICAL	1%	Yes	Yes

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
N020310-001	NIZORAL ANTI-DANDRUFF	KETOCONAZOLE	1%	SHAMPOO / TOPICAL		RLD, RS	1997-10-10

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	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nizoral	KETOCONAZOLE	Kramer Laboratories	a17b7424-ee7e-4fcc-b6b3-0904932ae319	2026-03-17	Warnings	Exact identifier application applno (NDA): 020310 application number: NDA020310 ndc (product): 55505-196
Nizoral	KETOCONAZOLE	Kramer Laboratories	f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88	2025-08-21	Warnings	Exact identifier application applno (NDA): 020310 application number: NDA020310
Nizoral	KETOCONAZOLE	Kramer Laboratories	8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb6	2025-07-11	Warnings	Exact identifier application applno (NDA): 020310 application number: NDA020310

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50580-895	Nizoral	Ketoconazole	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-895	Nizoral	Ketoconazole	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
55505-191	Nizoral	Ketoconazole	Kramer Laboratories	NDA AUTHORIZED GENERIC	Current
55505-191	Nizoral	Ketoconazole	Kramer Laboratories	NDA AUTHORIZED GENERIC	Current
55505-191	Nizoral	Ketoconazole	Kramer Laboratories	NDA AUTHORIZED	Current
55505-192	Nizoral	Ketoconazole	Kramer Laboratories	NDA	Current
55505-192	Nizoral	Ketoconazole	Kramer Laboratories	NDA	Current
55505-192	Nizoral	Ketoconazole	Kramer Laboratories	NDA	Current
55505-192	Nizoral	Ketoconazole	Kramer Laboratories	NDA	Current
55505-192	Nizoral	Ketoconazole	Kramer Laboratories	NDA	Current
55505-196	Nizoral	Ketoconazole	Kramer Laboratories	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85812	SUPPL	2026-05-04
85811	SUPPL	2026-05-04
84218	SUPPL	2025-11-19
84217	SUPPL	2025-11-19
81113	SUPPL	2025-02-06
81037	SUPPL	2025-02-06
78993	SUPPL	2024-07-08
78992	SUPPL	2024-07-08
77848	SUPPL	2024-03-15
77842	SUPPL	2024-03-15
75660	SUPPL	2023-10-03
75642	SUPPL	2023-10-03
73262	SUPPL	2023-01-20
73257	SUPPL	2023-01-20
71101	SUPPL	2022-05-19
71074	SUPPL	2022-05-16
66084	SUPPL	2021-02-03
62620	SUPPL	2020-04-21
62619	SUPPL	2020-04-21
61073	SUPPL	2019-11-27
61072	SUPPL	2019-11-27
56623	SUPPL	2018-12-04
23574	ORIG	2014-02-07
24761	SUPPL	2010-09-21
20594	ORIG	1997-10-10