Application 205955
- Type
- ANDA
- Sponsor
- SAWAI USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PITAVASTATIN CALCIUM | PITAVASTATIN CALCIUM | TABLET;ORAL | EQ 1MG BASE | No | No |
| 002 | PITAVASTATIN CALCIUM | PITAVASTATIN CALCIUM | TABLET;ORAL | EQ 2MG BASE | No | No |
| 003 | PITAVASTATIN CALCIUM | PITAVASTATIN CALCIUM | TABLET;ORAL | EQ 4MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205955-001 | PITAVASTATIN CALCIUM | PITAVASTATIN CALCIUM | EQ 1MG BASE | TABLET / ORAL | AB | 2017-02-03 | |
| A205955-002 | PITAVASTATIN CALCIUM | PITAVASTATIN CALCIUM | EQ 2MG BASE | TABLET / ORAL | AB | 2017-02-03 | |
| A205955-003 | PITAVASTATIN CALCIUM | PITAVASTATIN CALCIUM | EQ 4MG BASE | TABLET / ORAL | AB | 2017-02-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205955-001 | AB |
| A205955-002 | AB |
| A205955-003 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A205955-001 | PITAVASTATIN CALCIUM | EQ 1MG BASE | TABLET / ORAL | AB | 2017-02-03 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A205955-002 | PITAVASTATIN CALCIUM | EQ 2MG BASE | TABLET / ORAL | AB | 2017-02-03 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A205955-003 | PITAVASTATIN CALCIUM | EQ 4MG BASE | TABLET / ORAL | AB | 2017-02-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A205955-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A205955-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A205955-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pitavastatin | PITAVASTATIN CALCIUM | Golden State Medical Supply, Inc. | 2d5a1b78-4aa6-537b-e063-6394a90a522f | 2026-06-17 | Warnings, Adverse reactions | 205955 ANDA205955 |
| Pitavastatin | PITAVASTATIN CALCIUM | Upsher-Smith Laboratories, LLC | 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 | 2026-06-08 | Warnings, Adverse reactions | 205955 ANDA205955 |