Application 207994
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207994-001 | FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE / ORAL | AB | 2020-10-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207994-001 | 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 | A207994-001 | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE / ORAL | AB | 2020-10-14 | 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 | A207994-001 | 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 |
|---|---|---|---|---|---|---|
| Fingolimod | FINGOLIMOD | Zydus Pharmaceuticals USA Inc. | e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b3 | 2025-09-02 | Warnings, Adverse reactions | 207994 ANDA207994 68382-912 |
| Fingolimod | FINGOLIMOD | Zydus Lifesciences Limited | 5a0319b4-4bc6-4564-9687-9cfd5c1b23a8 | 2024-11-30 | 207994 ANDA207994 70771-1603 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68382-912 | Fingolimod | Fingolimod | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70771-1603 | Fingolimod | Fingolimod | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1603 | Fingolimod | Fingolimod | Zydus Lifesciences Limited | ANDA | Current |