Application 071529

Type: ANDA
Sponsor: SANDOZ

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A071529-001	THIOTHIXENE	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24
A071529-002	THIOTHIXENE	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24
A071529-003	THIOTHIXENE	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24
A071529-004	THIOTHIXENE	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071529-001	THIOTHIXENE	5MG	CAPSULE / ORAL	1987-06-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071529-002	THIOTHIXENE	1MG	CAPSULE / ORAL	1987-06-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071529-003	THIOTHIXENE	2MG	CAPSULE / ORAL	1987-06-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071529-004	THIOTHIXENE	10MG	CAPSULE / ORAL	1987-06-24	`3a93d1ddd44b…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-161	Thiothixene	Thiothixene	Rebel Distributors Corp	ANDA	Current