Application 071093

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THIOTHIXENE	THIOTHIXENE	CAPSULE;ORAL	10MG	No	No
002	THIOTHIXENE	THIOTHIXENE	CAPSULE;ORAL	1MG	No	No
003	THIOTHIXENE	THIOTHIXENE	CAPSULE;ORAL	2MG	No	No
004	THIOTHIXENE	THIOTHIXENE	CAPSULE;ORAL	5MG	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	Approval date
A071093-001	THIOTHIXENE	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23
A071093-002	THIOTHIXENE	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23
A071093-003	THIOTHIXENE	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23
A071093-004	THIOTHIXENE	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071093-001	AB
A071093-002	AB
A071093-003	AB
A071093-004	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071093-001	THIOTHIXENE	10MG	CAPSULE / ORAL	AB	1987-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071093-002	THIOTHIXENE	1MG	CAPSULE / ORAL	AB	1987-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071093-003	THIOTHIXENE	2MG	CAPSULE / ORAL	AB	1987-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071093-004	THIOTHIXENE	5MG	CAPSULE / ORAL	AB	1987-06-23	`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	A071093-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071093-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071093-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071093-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071093-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071093-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071093-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071093-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071093-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071093-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071093-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071093-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071093-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071093-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071093-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071093-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071093-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071093-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071093-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071093-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071093-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071093-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071093-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071093-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071093-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071093-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071093-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071093-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071093-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071093-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071093-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071093-004	AB	1	`5bbf6a4d5a75…`

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 · 4 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	Name fallback brand name: Thiothixene generic name: THIOTHIXENE
Thiothixene	THIOTHIXENE	Coupler LLC	313e893c-a6d0-46ae-e063-6294a90a6025	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Thiothixene generic name: THIOTHIXENE
Thiothixene	THIOTHIXENE	ANI Pharmaceuticals, Inc.	b067b400-66cd-422d-a631-9ce0c935d2b2	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Thiothixene generic name: THIOTHIXENE
thiothixene	THIOTHIXENE	Amneal Pharmaceuticals NY LLC	81c40311-7dc4-4332-8920-a39a8466aea6	2024-11-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: thiothixene generic name: THIOTHIXENE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1001	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1001	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1001	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1001	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2002	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2002	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2002	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2002	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3005	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3005	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3005	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3005	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5010	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5010	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5010	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5010	Thiothixene	thiothixene	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-587	Thiothixene	thiothixene	Mylan Institutional Inc.	ANDA	Current
51079-587	Thiothixene	thiothixene	Mylan Institutional Inc.	ANDA	Current
51079-587	Thiothixene	thiothixene	Mylan Institutional Inc.	ANDA	Current
51079-588	Thiothixene	thiothixene	Mylan Institutional Inc.	ANDA	Current
51079-588	Thiothixene	thiothixene	Mylan Institutional Inc.	ANDA	Current
51079-588	Thiothixene	thiothixene	Mylan Institutional Inc.	ANDA	Current
51079-589	Thiothixene	thiothixene	Mylan Institutional Inc.	ANDA	Current
51079-589	Thiothixene	thiothixene	Mylan Institutional Inc.	ANDA	Current
51079-589	Thiothixene	thiothixene	Mylan Institutional Inc.	ANDA	Current
53808-0817	Thiothixene	thiothixene	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1129	Thiothixene	thiothixene	DOH CENTRAL PHARMACY	ANDA	Current
68151-2486	Thiothixene	thiothixene	Carilion Materials Management	ANDA	Current
70518-0830	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-0830	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-1703	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-1703	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-1703	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-1703	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-2340	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-2340	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-2340	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current
70518-3147	Thiothixene	thiothixene	REMEDYREPACK INC.	ANDA	Current