Application 074378
- Type
- ANDA
- Sponsor
- OXFORD PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLIPIZIDE | GLIPIZIDE | TABLET;ORAL | 5MG | No | No |
| 002 | GLIPIZIDE | GLIPIZIDE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074378-001 | GLIPIZIDE | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 1994-11-28 | |
| A074378-002 | GLIPIZIDE | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 1994-11-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074378-001 | AB |
| A074378-002 | 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 | A074378-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 1994-11-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A074378-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 1994-11-28 | 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 | A074378-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A074378-002 | 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 |
|---|---|---|---|---|---|---|
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 9b405ff3-6ce5-460a-9406-db92e0e6ab1b | 2026-05-21 | Warnings, Adverse reactions | 074378 ANDA074378 |
| Glipizide | GLIPIZIDE | Preferred Pharmaceuticals Inc. | 410bf280-838d-45af-9b60-15f94ded7581 | 2026-01-28 | Warnings, Adverse reactions | 074378 ANDA074378 |
| Glipizide | GLIPIZIDE | Proficient Rx LP | f5d7a98c-d1d4-43b9-8d7e-830a33ae0c24 | 2026-01-01 | Warnings, Adverse reactions | 074378 ANDA074378 |
| Glipizide | GLIPIZIDE | Oxford Pharmaceuticals, LLC | 87cd4930-ba68-4acf-bf74-619c477b557d | 2025-04-29 | Warnings, Adverse reactions | 074378 ANDA074378 |