Application 021806

Type: NDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANDAZOLE	METRONIDAZOLE	GEL;VAGINAL	0.75%	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
N021806-001	VANDAZOLE	METRONIDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021806-001	BX

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX		2005-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX		2005-05-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX		2005-05-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX		2005-05-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`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	N021806-001	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021806-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021806-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021806-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021806-001	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021806-001	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021806-001	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021806-001	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021806-001	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021806-001	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021806-001	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021806-001	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021806-001	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021806-001	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021806-001	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021806-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021806-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021806-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021806-001	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021806-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021806-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021806-001	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021806-001	BX	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021806-001	BX	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021806-001	BX	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021806-001	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021806-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021806-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021806-001	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021806-001	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021806-001	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021806-001	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021806-001	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021806-001	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021806-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021806-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021806-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021806-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021806-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021806-001	BX	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021806-001	7456207	2024-09-22	Drug product	2011-01-20	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vandazole	METRONIDAZOLE	Upsher-smith Laboratories, LLC	27d71471-8f89-4a1e-8c55-020a58961454	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021806 application number: NDA021806 ndc (product): 0245-0860

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
0245-0860	Vandazole	Metronidazole	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0860	Vandazole	Metronidazole	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0860	Vandazole	Metronidazole	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0860	Vandazole	Metronidazole	Upsher-Smith Laboratories, LLC	NDA	Current
53002-7341	Vandazole	Metronidazole	RPK Pharmaceuticals, Inc.	NDA	Current
70518-2400	Vandazole	Metronidazole	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66233	SUPPL	2021-02-16
66212	SUPPL	2021-02-16
28634	SUPPL	2011-02-10
37685	SUPPL	2011-02-09
21823	ORIG	2007-06-29
37684	ORIG	2005-05-25
28633	ORIG	2005-05-25