Application 090348

Type: ANDA
Sponsor: WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 20MG BASE	No	No
002	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 40MG BASE	No	No
003	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 60MG BASE	No	No
004	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 80MG BASE	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	TE codes	Approval date
A090348-001	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05
A090348-002	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05
A090348-003	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05
A090348-004	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090348-001	AB
A090348-002	AB
A090348-003	AB
A090348-004	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 5 of 5 · 176 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
2022-10-28 04:53 UTC	2022-10	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090348-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090348-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090348-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090348-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090348-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090348-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090348-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090348-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090348-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090348-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090348-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090348-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090348-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090348-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090348-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090348-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090348-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090348-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090348-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090348-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-004	AB	1	`2680178bc6a6…`

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
Ziprasidone	ZIPRASIDONE	Chartwell RX, LLC	7fbd9460-78a3-4160-9986-3a113de752a6	2023-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090348 application number: ANDA090348

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55648-991	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt Limited	ANDA	Current
55648-992	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt Limited	ANDA	Current
55648-993	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt Limited	ANDA	Current
55648-994	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt Limited	ANDA	Current
64679-991	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-991	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-992	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-992	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-993	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-993	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-994	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-994	Ziprasidone hydrochloride	Ziprasidone hydrochloride	Wockhardt USA LLC.	ANDA	Current
64725-0993	Ziprasidone hydrochloride	Ziprasidone hydrochloride	TYA Pharmaceuticals	ANDA	Current
64725-0994	Ziprasidone hydrochloride	Ziprasidone hydrochloride	TYA Pharmaceuticals	ANDA	Current