Application 211908

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	INJECTABLE;INTRAMUSCULAR	EQ 20MG BASE/ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211908-001	ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP		2019-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211908-001	AP

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211908-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211908-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211908-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211908-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211908-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211908-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211908-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211908-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211908-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211908-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211908-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211908-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211908-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211908-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211908-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211908-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211908-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211908-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211908-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211908-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211908-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211908-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211908-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211908-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211908-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211908-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211908-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211908-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211908-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211908-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211908-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211908-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211908-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211908-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211908-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211908-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211908-001	AP	1	`a50c72e98297…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ziprasidone Mesylate	ZIPRASIDONE MESYLATE	Fosun Pharma USA Inc.	b28a4f3d-0aae-050d-e053-2995a90aa4a6	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908 ndc (product): 72266-160
Ziprasidone Mesylate	ZIPRASIDONE MESYLATE	Fosun Pharma USA Inc.	90f55022-8d58-4bfb-9464-9bf11395ae17	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908 ndc (product): 72266-160
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Gland Pharma Limited	77a10f48-e300-465f-81b5-54be38daa4b3	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908 ndc (product): 68083-340
ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	HF Acquisition Co LLC, DBA HealthFirst	c75971f8-9640-a6e8-e053-2995a90af654	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908 ndc (product): 51662-1564
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Dr.Reddy's Laboratories, Inc.	3cb79985-1207-602e-2dda-a118133b4c60	2021-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908 ndc (product): 43598-848
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Dr.Reddy's Laboratories, Inc.	6fd6fc45-20c4-e223-3532-ce37aa02b71c	2021-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908 ndc (product): 43598-061

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-061	ziprasidone mesylate	ziprasidone mesylate	Dr.Reddy's Laboratories, Inc.	ANDA	Current
43598-061	ziprasidone mesylate	ziprasidone mesylate	Dr.Reddy's Laboratories, Inc.	ANDA	Current
43598-848	ziprasidone mesylate	ziprasidone mesylate	Dr.Reddy's Laboratories, Inc.	ANDA	Current
43598-848	ziprasidone mesylate	ziprasidone mesylate	Dr.Reddy's Laboratories, Inc.	ANDA	Current
43598-848	ziprasidone mesylate	ziprasidone mesylate	Dr.Reddy's Laboratories, Inc.	ANDA	Current
43598-848	ziprasidone mesylate	ziprasidone mesylate	Dr. Reddy	ANDA	Current
43598-848	ziprasidone mesylate	ziprasidone mesylate	Dr. Reddy	ANDA	Current
51662-1564	ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
68083-340	ziprasidone mesylate	ziprasidone mesylate	Gland Pharma Limited	ANDA	Current
68083-340	ziprasidone mesylate	ziprasidone mesylate	Gland Pharma Limited	ANDA	Current
68083-340	ziprasidone mesylate	ziprasidone mesylate	Gland Pharma Limited	ANDA	Current
68083-340	ziprasidone mesylate	ziprasidone mesylate	Gland Pharma Limited	ANDA	Current
72266-160	ziprasidone mesylate	ziprasidone mesylate	Fosun Pharma USA Inc.	ANDA	Current
72266-160	Ziprasidone Mesylate	Ziprasidone Mesylate	Fosun Pharma USA Inc.	ANDA	Current
72266-160	Ziprasidone Mesylate	Ziprasidone Mesylate	Fosun Pharma USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62180	ORIG	2020-03-17