Application 075201

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDAPAMIDE	INDAPAMIDE	TABLET;ORAL	1.25MG	No	No
002	INDAPAMIDE	INDAPAMIDE	TABLET;ORAL	2.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075201-001	INDAPAMIDE	INDAPAMIDE	1.25MG	TABLET / ORAL			1998-12-04
A075201-002	INDAPAMIDE	INDAPAMIDE	2.5MG	TABLET / ORAL			1998-12-04

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1998-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1998-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075201-001	INDAPAMIDE	1.25MG	TABLET / ORAL		1998-12-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075201-002	INDAPAMIDE	2.5MG	TABLET / ORAL		1998-12-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075201-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075201-002	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A075201-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075201-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075201-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075201-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075201-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075201-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075201-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075201-002	AB	1	`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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indapamide	INDAPAMIDE	Preferred Pharmaceuticals Inc.	59cd3331-7afe-432a-8b50-39533fd5f392	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	8a16fc49-7a36-4873-9652-194ebb0bac68	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	5b55449f-4242-489d-8ba7-5baf4ba1a53a	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	962b20df-88ff-4ab7-a900-135adb6c1d74	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	A-S Medication Solutions	7fe643f7-a1df-4e9a-9d45-f20b8512a04e	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	A-S Medication Solutions	c678bc6b-a01b-4238-8bcb-490bc6d41d72	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	Golden State Medical Supply, Inc.	71feffd5-4056-2b53-e053-2995a90a5b73	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	365d26ea-d02d-4fcf-9c99-54c251ef0483	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	6a643c56-794a-4289-8390-5d76fa2709b3	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	ANI Pharmaceuticals, Inc.	deb83f97-6c61-4a09-bed6-18dcf1183405	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	Direct_Rx	25b5bb79-400d-e266-e063-6394a90abfd8	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	Rising Pharma Holdings, Inc.	0687ed93-4761-4f9c-887d-95309c03f60e	2023-06-26	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE
Indapamide	INDAPAMIDE	Actavis Pharma, Inc.	a8a4ec2c-9d4b-482b-ad29-88185c96db74	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Indapamide generic name: INDAPAMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43975-217	INDAPAMIDE	INDAPAMIDE	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-217	INDAPAMIDE	INDAPAMIDE	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-217	INDAPAMIDE	INDAPAMIDE	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-217	INDAPAMIDE	INDAPAMIDE	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-217	INDAPAMIDE	INDAPAMIDE	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-304	INDAPAMIDE	INDAPAMIDE	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-304	INDAPAMIDE	INDAPAMIDE	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-304	INDAPAMIDE	INDAPAMIDE	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-304	INDAPAMIDE	INDAPAMIDE	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-304	INDAPAMIDE	INDAPAMIDE	ANI Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8561	ORIG	1998-12-04