Application 200477
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A200477-001 | RISEDRONATE SODIUM | 5MG | TABLET / ORAL | 2015-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200477-002 | RISEDRONATE SODIUM | 30MG | TABLET / ORAL | 2015-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200477-003 | RISEDRONATE SODIUM | 35MG | TABLET / ORAL | 2015-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200477-004 | RISEDRONATE SODIUM | 75MG | TABLET / ORAL | 2014-06-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200477-005 | RISEDRONATE SODIUM | 150MG | TABLET / ORAL | 2014-06-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200477-001 | RISEDRONATE SODIUM | 5MG | TABLET / ORAL | 2015-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200477-002 | RISEDRONATE SODIUM | 30MG | TABLET / ORAL | 2015-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200477-003 | RISEDRONATE SODIUM | 35MG | TABLET / ORAL | 2015-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200477-004 | RISEDRONATE SODIUM | 75MG | TABLET / ORAL | 2014-06-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200477-005 | RISEDRONATE SODIUM | 150MG | TABLET / ORAL | 2014-06-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200477-001 | RISEDRONATE SODIUM | 5MG | TABLET / ORAL | 2015-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200477-002 | RISEDRONATE SODIUM | 30MG | TABLET / ORAL | 2015-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200477-003 | RISEDRONATE SODIUM | 35MG | TABLET / ORAL | 2015-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200477-004 | RISEDRONATE SODIUM | 75MG | TABLET / ORAL | 2014-06-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200477-005 | RISEDRONATE SODIUM | 150MG | TABLET / ORAL | 2014-06-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200477-001 | RISEDRONATE SODIUM | 5MG | TABLET / ORAL | 2015-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200477-002 | RISEDRONATE SODIUM | 30MG | TABLET / ORAL | 2015-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200477-003 | RISEDRONATE SODIUM | 35MG | TABLET / ORAL | 2015-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200477-004 | RISEDRONATE SODIUM | 75MG | TABLET / ORAL | 2014-06-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200477-005 | RISEDRONATE SODIUM | 150MG | TABLET / ORAL | 2014-06-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200477-001 | RISEDRONATE SODIUM | 5MG | TABLET / ORAL | 2015-11-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200477-002 | RISEDRONATE SODIUM | 30MG | TABLET / ORAL | 2015-11-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200477-003 | RISEDRONATE SODIUM | 35MG | TABLET / ORAL | 2015-11-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200477-004 | RISEDRONATE SODIUM | 75MG | TABLET / ORAL | 2014-06-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200477-005 | RISEDRONATE SODIUM | 150MG | TABLET / ORAL | 2014-06-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200477-001 | RISEDRONATE SODIUM | 5MG | TABLET / ORAL | 2015-11-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200477-002 | RISEDRONATE SODIUM | 30MG | TABLET / ORAL | 2015-11-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200477-003 | RISEDRONATE SODIUM | 35MG | TABLET / ORAL | 2015-11-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200477-004 | RISEDRONATE SODIUM | 75MG | TABLET / ORAL | 2014-06-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200477-005 | RISEDRONATE SODIUM | 150MG | TABLET / ORAL | 2014-06-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200477-001 | RISEDRONATE SODIUM | 5MG | TABLET / ORAL | 2015-11-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200477-002 | RISEDRONATE SODIUM | 30MG | TABLET / ORAL | 2015-11-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200477-003 | RISEDRONATE SODIUM | 35MG | TABLET / ORAL | 2015-11-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200477-004 | RISEDRONATE SODIUM | 75MG | TABLET / ORAL | 2014-06-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200477-005 | RISEDRONATE SODIUM | 150MG | TABLET / ORAL | 2014-06-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200477-001 | RISEDRONATE SODIUM | 5MG | TABLET / ORAL | 2015-11-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200477-002 | RISEDRONATE SODIUM | 30MG | TABLET / ORAL | 2015-11-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200477-003 | RISEDRONATE SODIUM | 35MG | TABLET / ORAL | 2015-11-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200477-004 | RISEDRONATE SODIUM | 75MG | TABLET / ORAL | 2014-06-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200477-005 | RISEDRONATE SODIUM | 150MG | TABLET / ORAL | 2014-06-10 | 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.
| 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 | Risedronate Sodium RISEDRONATE SODIUM |
| Risedronate Sodium | RISEDRONATE SODIUM | Apotex Corp. | b90f2e5b-10b8-29a7-0360-31bd0dae0ec2 | 2026-03-02 | Warnings, Adverse reactions | Risedronate Sodium RISEDRONATE SODIUM |
| Risedronate Sodium | RISEDRONATE SODIUM | Macleods Pharmaceuticals Limited | 62aff8d6-a2f7-4c7e-a102-c70105ac3792 | 2026-03-01 | Warnings, Adverse reactions | Risedronate Sodium RISEDRONATE SODIUM |
| risedronate sodium | RISEDRONATE SODIUM | Sun Pharmaceutical Industries, Inc. | e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339 | 2026-02-17 | Warnings, Adverse reactions | risedronate sodium RISEDRONATE SODIUM |
| Risedronate Sodium | RISEDRONATE SODIUM | Mylan Pharmaceuticals, Inc. | f715718a-407d-4e2a-9834-74a8f1361d03 | 2026-02-12 | Warnings, Adverse reactions | Risedronate Sodium RISEDRONATE SODIUM |
| Risedronate Sodium | RISEDRONATE SODIUM | Aurobindo Pharma Limited | 89896dfe-f69d-4cb3-bb71-7a7c611071fa | 2026-02-11 | Warnings, Adverse reactions | Risedronate Sodium RISEDRONATE SODIUM |
| Risedronate Sodium | RISEDRONATE SODIUM | Aurobindo Pharma Limited | a42a35e6-3e08-4b4f-ae56-47d4aec2322a | 2026-02-10 | Warnings, Adverse reactions | Risedronate Sodium RISEDRONATE SODIUM |
| Actonel | RISEDRONATE SODIUM | Allergan, Inc. | 24ed00e0-25e2-49a8-97fc-66c1b417dc0b | 2026-02-04 | Warnings, Adverse reactions | RISEDRONATE SODIUM |
| Atelvia | RISEDRONATE SODIUM | Allergan, Inc. | c8b9ab88-1a26-46c3-80ec-4eaa45202021 | 2026-02-03 | Warnings, Adverse reactions | RISEDRONATE SODIUM |
| Risedronate Sodium | RISEDRONATE SODIUM | Mylan Pharmaceuticals, Inc. | c89430be-15f1-4b8b-ab7e-738de716ee7d | 2026-02-03 | Warnings, Adverse reactions | Risedronate Sodium RISEDRONATE SODIUM |
| Risedronate Sodium | RISEDRONATE SODIUM | Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd | d60a56cb-ef49-4447-9043-7b6879a20d75 | 2025-12-16 | Warnings, Adverse reactions | Risedronate Sodium RISEDRONATE SODIUM |
| Risedronate Sodium | RISEDRONATE SODIUM | Proficient Rx LP | 81702f21-3117-49ce-8e9b-2aa2648ba7c3 | 2022-11-01 | Warnings, Adverse reactions | Risedronate Sodium RISEDRONATE SODIUM |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | Sun Pharmaceutical Industires Inc. | 1d9e520b-2fa6-4603-b397-f0fc24fae775 | 2020-09-09 | Warnings, Adverse reactions | RISEDRONATE SODIUM RISEDRONATE SODIUM |
NDC Listings For This Application#
| 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 |