Application 200477

Type: ANDA
Sponsor: MYLAN

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
004	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	75MG	No	No
005	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	150MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A200477-001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET / ORAL	2015-11-30
A200477-002	RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET / ORAL	2015-11-30
A200477-003	RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET / ORAL	2015-11-30
A200477-004	RISEDRONATE SODIUM	RISEDRONATE SODIUM	75MG	TABLET / ORAL	2014-06-10
A200477-005	RISEDRONATE SODIUM	RISEDRONATE SODIUM	150MG	TABLET / ORAL	2014-06-10

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 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A200477-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	2015-11-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200477-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	2015-11-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200477-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	2015-11-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200477-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	2014-06-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200477-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	2014-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200477-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	2015-11-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200477-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	2015-11-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200477-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	2015-11-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200477-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	2014-06-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200477-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	2014-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200477-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	2015-11-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200477-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	2015-11-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200477-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	2015-11-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200477-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	2014-06-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200477-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	2014-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200477-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	2015-11-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200477-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	2015-11-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200477-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	2015-11-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200477-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	2014-06-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200477-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	2014-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200477-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	2015-11-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200477-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	2015-11-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200477-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	2015-11-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200477-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	2014-06-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200477-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	2014-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200477-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	2015-11-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200477-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	2015-11-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200477-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	2015-11-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200477-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	2014-06-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200477-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	2014-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200477-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	2015-11-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200477-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	2015-11-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200477-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	2015-11-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200477-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	2014-06-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200477-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	2014-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200477-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	2015-11-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200477-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	2015-11-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200477-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	2015-11-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200477-004	RISEDRONATE SODIUM	75MG	TABLET / ORAL	2014-06-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200477-005	RISEDRONATE SODIUM	150MG	TABLET / ORAL	2014-06-10	`1c564ffb4f44…`

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
Risedronate Sodium	RISEDRONATE SODIUM	Teva Pharmaceuticals USA, Inc.	dddcd321-4d2e-4643-bf3c-7b752b33ba39	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Apotex Corp.	b90f2e5b-10b8-29a7-0360-31bd0dae0ec2	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Macleods Pharmaceuticals Limited	62aff8d6-a2f7-4c7e-a102-c70105ac3792	2026-03-01	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
risedronate sodium	RISEDRONATE SODIUM	Sun Pharmaceutical Industries, Inc.	e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: risedronate sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Mylan Pharmaceuticals, Inc.	f715718a-407d-4e2a-9834-74a8f1361d03	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Aurobindo Pharma Limited	89896dfe-f69d-4cb3-bb71-7a7c611071fa	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Aurobindo Pharma Limited	a42a35e6-3e08-4b4f-ae56-47d4aec2322a	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Actonel	RISEDRONATE SODIUM	Allergan, Inc.	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: RISEDRONATE SODIUM
Atelvia	RISEDRONATE SODIUM	Allergan, Inc.	c8b9ab88-1a26-46c3-80ec-4eaa45202021	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Mylan Pharmaceuticals, Inc.	c89430be-15f1-4b8b-ab7e-738de716ee7d	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	d60a56cb-ef49-4447-9043-7b6879a20d75	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
Risedronate Sodium	RISEDRONATE SODIUM	Proficient Rx LP	81702f21-3117-49ce-8e9b-2aa2648ba7c3	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Risedronate Sodium generic name: RISEDRONATE SODIUM
RISEDRONATE SODIUM	RISEDRONATE SODIUM	Sun Pharmaceutical Industires Inc.	1d9e520b-2fa6-4603-b397-f0fc24fae775	2020-09-09	Warnings, Adverse reactions	Name fallback brand name: RISEDRONATE SODIUM generic name: RISEDRONATE SODIUM

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4044	Risedronate Sodium	risedronate sodium	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4114	Risedronate Sodium	risedronate sodium	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4150	Risedronate Sodium	risedronate sodium	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4150	Risedronate Sodium	risedronate sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4714	Risedronate Sodium	risedronate sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4714	Risedronate Sodium	risedronate sodium	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4714	Risedronate Sodium	risedronate sodium	Mylan Pharmaceuticals Inc.	ANDA	Current