Application 211642

Type: ANDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THIOTHIXENE	THIOTHIXENE	CAPSULE;ORAL	1MG	No	No
002	THIOTHIXENE	THIOTHIXENE	CAPSULE;ORAL	2MG	No	No
003	THIOTHIXENE	THIOTHIXENE	CAPSULE;ORAL	5MG	No	Yes
004	THIOTHIXENE	THIOTHIXENE	CAPSULE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211642-001	THIOTHIXENE	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05
A211642-002	THIOTHIXENE	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05
A211642-003	THIOTHIXENE	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05
A211642-004	THIOTHIXENE	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211642-001	AB
A211642-002	AB
A211642-003	AB
A211642-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-001	THIOTHIXENE	1MG	CAPSULE / ORAL	AB		2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-002	THIOTHIXENE	2MG	CAPSULE / ORAL	AB		2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-003	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	RS	2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-004	THIOTHIXENE	10MG	CAPSULE / ORAL	AB		2019-04-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211642-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211642-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211642-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211642-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211642-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211642-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211642-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211642-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211642-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211642-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211642-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211642-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211642-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211642-004	AB	1	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211642-001	CGT	2019-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211642-002	CGT	2019-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211642-003	CGT	2019-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211642-004	CGT	2019-10-02	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211642-001	CGT	2019-10-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211642-002	CGT	2019-10-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211642-003	CGT	2019-10-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211642-004	CGT	2019-10-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211642-001	CGT	2019-10-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211642-002	CGT	2019-10-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211642-003	CGT	2019-10-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211642-004	CGT	2019-10-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211642-001	CGT	2019-10-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211642-002	CGT	2019-10-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211642-003	CGT	2019-10-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211642-004	CGT	2019-10-02	`ea99ee380514…`

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
Thiothixene	THIOTHIXENE	Golden State Medical Supply, Inc.	9480a406-c85b-ba06-e053-2a95a90a0912	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211642 application number: ANDA211642 ndc (product): 51407-276 ndc (product): 51407-278 ndc (product): 51407-275 ndc (product): 51407-277
Thiothixene	THIOTHIXENE	Coupler LLC	313e893c-a6d0-46ae-e063-6294a90a6025	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211642 application number: ANDA211642
Thiothixene	THIOTHIXENE	ANI Pharmaceuticals, Inc.	b067b400-66cd-422d-a631-9ce0c935d2b2	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211642 application number: ANDA211642 ndc (product): 70954-015 ndc (product): 70954-017 ndc (product): 70954-016 ndc (product): 70954-014

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-275	Thiothixene	Thiothixene	Golden State Medical Supply, Inc.	ANDA	Current
51407-275	Thiothixene	Thiothixene	Golden State Medical Supply, Inc.	ANDA	Current
51407-276	Thiothixene	Thiothixene	Golden State Medical Supply, Inc.	ANDA	Current
51407-276	Thiothixene	Thiothixene	Golden State Medical Supply, Inc.	ANDA	Current
51407-277	Thiothixene	Thiothixene	Golden State Medical Supply, Inc.	ANDA	Current
51407-277	Thiothixene	Thiothixene	Golden State Medical Supply, Inc.	ANDA	Current
51407-278	Thiothixene	Thiothixene	Golden State Medical Supply, Inc.	ANDA	Current
51407-278	Thiothixene	Thiothixene	Golden State Medical Supply, Inc.	ANDA	Current
70518-2544	Thiothixene	Thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-2544	Thiothixene	Thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-2594	Thiothixene	Thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-2594	Thiothixene	Thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-2594	Thiothixene	Thiothixene	REMEDYREPACK INC.	ANDA	Current
70954-014	Thiothixene	Thiothixene	Novitium Pharma LLC	ANDA	Current
70954-014	Thiothixene	Thiothixene	Novitium Pharma LLC	ANDA	Current
70954-015	Thiothixene	Thiothixene	Novitium Pharma LLC	ANDA	Current
70954-015	Thiothixene	Thiothixene	Novitium Pharma LLC	ANDA	Current
70954-016	Thiothixene	Thiothixene	Novitium Pharma LLC	ANDA	Current
70954-016	Thiothixene	Thiothixene	Novitium Pharma LLC	ANDA	Current
70954-017	Thiothixene	Thiothixene	Novitium Pharma LLC	ANDA	Current
70954-017	Thiothixene	Thiothixene	Novitium Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58823	ORIG	2019-05-22