Application 019579

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TERAZOL 7	TERCONAZOLE	CREAM;VAGINAL	0.4%	Yes	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
N019579-001	TERAZOL 7	TERCONAZOLE	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL		RLD	1987-12-31

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019579-001	TERAZOL 7	0.4%	CREAM / VAGINAL	RLD	1987-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019579-001	TERAZOL 7	0.4%	CREAM / VAGINAL	RLD	1987-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019579-001	TERAZOL 7	0.4%	CREAM / VAGINAL	RLD	1987-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / VAGINAL	RLD	1987-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / VAGINAL	RLD	1987-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / VAGINAL	RLD	1987-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / VAGINAL	RLD	1987-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019579-001	TERAZOL 7	0.4%	CREAM / VAGINAL	RLD	1987-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019579-001	TERAZOL 7	0.4%	CREAM / VAGINAL	RLD	1987-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019579-001	TERAZOL 7	0.4%	CREAM / VAGINAL	RLD	1987-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019579-001	TERAZOL 7	0.4%	CREAM / VAGINAL	RLD	1987-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019579-001	TERAZOL 7	0.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-12-31	`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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terconazole	TERCONAZOLE	Padagis Israel Pharmaceuticals Ltd	207e9cf2-e8ec-43d7-9c11-46283c9cdb37	2026-08-11	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole	TERCONAZOLE	Cosette Pharmaceuticals, Inc.	38cd1718-6b3c-415d-a17f-7b399adb0ba2	2026-05-07	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole Vaginal Cream 0.8%	TERCONAZOLE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	f59448bd-f730-46d2-a785-c2d6205579ff	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole	TERCONAZOLE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	10e84353-93d2-461d-8b79-e9294df047ae	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole	TERCONAZOLE	Sun Pharmaceutical Industries, Inc.	6d7a8fd6-7837-427e-9b18-89e33351b05e	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole	TERCONAZOLE	Sun Pharmaceutical Industries, Inc.	b4f50a11-bd39-4023-9145-2da60f6b085f	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole	TERCONAZOLE	Sun Pharmaceutical Industries, Inc.	2b3923b5-0a97-428c-b8d2-4a3ceb3447a1	2025-05-27	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole	TERCONAZOLE	NuCare Pharmaceuticals,Inc.	71c13149-396e-edc6-e053-2a95a90af50c	2024-12-24	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole	TERCONAZOLE	A-S Medication Solutions	b922feb5-cd85-4f13-9a18-913e58f8da83	2023-12-09	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole	TERCONAZOLE	A-S Medication Solutions	e0a5e163-741f-4f5e-9d2e-b733f9879c99	2023-10-31	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole Vaginal Cream 0.8%	TERCONAZOLE	A-S Medication Solutions	9b1c38ac-ebf3-471c-bcdf-1ff8ad197f91	2023-01-03	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE
Terconazole	TERCONAZOLE	A-S Medication Solutions	1e32bf0d-2a93-44ac-ae28-8d34e10380c0	2023-01-03	Warnings, Adverse reactions	Name fallback generic name: TERCONAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3196	TERCONAZOLE	TERCONAZOLE	Actavis Pharma, Inc	NDA AUTHORIZED GENERIC	Current
50090-2341	TERCONAZOLE	TERCONAZOLE	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50458-535	Terazol 7	TERCONAZOLE	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-535	Terazol 7	TERCONAZOLE	Janssen Pharmaceuticals, Inc.	NDA	Current
52959-811	TERCONAZOLE	terconazole	H.J. Harkins Company, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17464	SUPPL	2014-07-25
11541	SUPPL	2014-07-24
1397	SUPPL	2013-10-01
33802	SUPPL	2013-09-27
11540	SUPPL	2004-07-01
17463	SUPPL	2004-06-30
17462	SUPPL	2003-09-30
17461	SUPPL	2003-03-25
1396	SUPPL	2003-03-25
33801	SUPPL	2003-03-20
11539	SUPPL	2003-03-20