Application 203533

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	5MG	No	No
002	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	30MG	No	No
003	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	35MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203533-001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09
A203533-002	RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09
A203533-003	RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203533-001	AB
A203533-002	AB
A203533-003	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 4 · 126 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	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203533-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-12-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203533-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2016-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203533-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-12-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203533-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203533-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203533-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203533-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203533-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203533-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203533-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203533-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203533-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203533-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203533-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203533-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203533-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203533-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203533-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203533-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203533-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203533-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203533-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203533-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203533-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203533-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203533-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203533-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203533-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203533-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203533-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203533-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203533-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203533-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203533-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203533-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203533-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203533-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203533-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203533-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203533-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203533-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203533-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203533-001	AB	1	`1e350fbaab3a…`

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
Risedronate Sodium	RISEDRONATE SODIUM	Macleods Pharmaceuticals Limited	62aff8d6-a2f7-4c7e-a102-c70105ac3792	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203533 application number: ANDA203533 ndc (product): 33342-109 ndc (product): 33342-108 ndc (product): 33342-107

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-107	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-107	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-107	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-107	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-108	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-108	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-108	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-108	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-109	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-109	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-109	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-109	Risedronate Sodium	Risedronate Sodium	Macleods Pharmaceuticals Limited	ANDA	Current