Application 214651
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 7MG | No | No |
| 002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 14MG | No | No |
| 003 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 21MG | No | No |
| 004 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 28MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214651-001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2021-08-09 | |
| A214651-002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2021-08-09 | |
| A214651-003 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2021-08-09 | |
| A214651-004 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2021-08-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214651-001 | AB |
| A214651-002 | AB |
| A214651-003 | AB |
| A214651-004 | 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 | A214651-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2021-08-09 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A214651-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2021-08-09 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A214651-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2021-08-09 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A214651-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2021-08-09 | 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 | A214651-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A214651-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A214651-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A214651-004 | 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 |
|---|---|---|---|---|---|---|
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | 2b2dcd54-47e0-494b-85d2-c28c3adbe737 | 2022-11-05 | Warnings, Adverse reactions | 214651 ANDA214651 59651-404 59651-405 59651-407 59651-406 59651-408 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59651-404 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-404 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-405 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-405 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-406 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-406 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-407 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-407 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-408 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-408 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |