Application 021618

Type: NDA
Sponsor: MISSION PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TINDAMAX	TINIDAZOLE	TABLET;ORAL	250MG	Yes	No
002	TINDAMAX	TINIDAZOLE	TABLET;ORAL	500MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021618-001	TINDAMAX	TINIDAZOLE	250MG	TABLET / ORAL	AB	RLD	2004-05-17
N021618-002	TINDAMAX	TINIDAZOLE	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021618-001	AB
N021618-002	AB

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021618-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021618-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021618-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021618-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021618-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021618-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021618-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021618-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021618-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021618-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021618-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021618-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021618-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021618-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021618-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021618-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021618-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021618-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021618-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021618-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021618-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021618-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021618-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021618-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021618-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021618-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021618-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021618-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021618-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021618-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021618-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021618-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021618-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021618-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021618-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021618-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021618-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021618-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021618-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021618-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinidazole	TINIDAZOLE	BioComp Pharma, Inc.	f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021618 application number: NDA021618 ndc (product): 44523-450
Tindamax	TINIDAZOLE	Mission Pharmacal Company	a0d01539-8413-4703-94cc-d221918630a1	2021-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021618 application number: NDA021618 ndc (product): 0178-8500 ndc (product): 0178-8250

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0178-8250	Tindamax	tinidazole	Mission Pharmacal Company	NDA	Current
0178-8250	Tindamax	tinidazole	Mission Pharmacal Company	NDA	Current
0178-8250	Tindamax	tinidazole	Mission Pharmacal Company	NDA	Current
0178-8250	Tindamax	tinidazole	Mission Pharmacal Company	NDA	Current
0178-8500	Tindamax	tinidazole	Mission Pharmacal Company	NDA	Current
0178-8500	Tindamax	tinidazole	Mission Pharmacal Company	NDA	Current
0178-8500	Tindamax	tinidazole	Mission Pharmacal Company	NDA	Current
0178-8500	Tindamax	tinidazole	Mission Pharmacal Company	NDA	Current
44523-425	Tinidazole	Tinidazole	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
44523-450	Tinidazole	Tinidazole	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69679	SUPPL	2021-12-20
69612	SUPPL	2021-12-17
64908	SUPPL	2020-10-14
64897	SUPPL	2020-10-14
59003	SUPPL	2019-06-10
59001	SUPPL	2019-06-10
37343	SUPPL	2007-05-29
5864	SUPPL	2007-05-29
42235	ORIG	2004-08-30
15880	ORIG	2004-05-27
5863	ORIG	2004-05-26