Application 074619
- Type
- ANDA
- Sponsor
- BARR LABS INC
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 |
|---|---|---|---|---|---|---|---|
| A074619-001 | GLIPIZIDE | GLIPIZIDE | 5MG | TABLET / ORAL | 1997-04-04 | ||
| A074619-002 | GLIPIZIDE | GLIPIZIDE | 10MG | TABLET / ORAL | 1997-04-04 |
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 | A074619-001 | GLIPIZIDE | 5MG | TABLET / ORAL | 1997-04-04 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A074619-002 | GLIPIZIDE | 10MG | TABLET / ORAL | 1997-04-04 | 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 |
|---|---|---|---|---|---|---|
| Glucotrol XL | GLIPIZIDE | Roerig | eed99b60-d043-4249-9b2a-f05e46fb588d | 2026-07-21 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | 03151cb5-d32b-4484-8f2a-8c5d24c7f6f1 | 2026-07-14 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | ANI Pharmaceuticals, Inc. | 252ba4e0-8dc3-43e3-be00-32570dc095bd | 2026-07-13 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | c2aadc88-22d2-467c-b2cb-03efb5a1f1c1 | 2026-07-02 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | 376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb4 | 2026-06-29 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | 212897cb-7de7-4711-aaf4-44234f950e9f | 2026-06-26 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | American Health Packaging | ff6805bb-b5f0-46d3-bf1d-3333b63ff1ae | 2026-06-24 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | St. Mary's Medical Park Pharmacy | 1b2ef6e2-5e7c-761e-e063-6294a90addd0 | 2026-06-22 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals, Inc. | 4c4dfe64-d1c5-65ec-e063-6394a90aead5 | 2026-06-19 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 06fb6c56-5609-41d9-8389-eba81432218d | 2026-06-11 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 5ca7e38b-84cb-4043-b97e-e2f5cd82b442 | 2026-06-11 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | Coupler LLC | 53e650f1-f755-e3ad-e063-6294a90ae309 | 2026-06-10 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | 0df8f606-97b3-463c-a132-338cf4630a71 | 2026-06-10 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | c8cfd137-7b41-460f-a463-141c9d1985ff | 2026-06-04 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | St. Mary's Medical Park Pharmacy | 0ccc17ca-fff8-0449-e063-6294a90af36d | 2026-06-03 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 9b405ff3-6ce5-460a-9406-db92e0e6ab1b | 2026-05-21 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 69a21bd3-3364-4035-b098-3808cc8cf8b2 | 2026-05-17 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | c582d7d0-4db0-4296-8131-baefd1a671b2 | 2026-05-17 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | Coupler LLC | 51b35391-7672-c02f-e063-6294a90af54e | 2026-05-13 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 2aa01a7e-a703-426f-9cd3-70b88d0a8e7f | 2026-05-13 | Warnings, Adverse reactions | Glipizide GLIPIZIDE |