Application 078422
- Type
- ANDA
- Sponsor
- IPCA LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 850MG | No | No |
| 003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078422-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | ||
| A078422-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | ||
| A078422-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078422-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2007-08-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078422-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2007-08-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078422-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2007-08-06 | 301d65b070ca… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE TABLET | Quallent Pharmaceuticals Health LLC | f39ee08d-73db-71b9-e053-2995a90a877c | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Precision Dose, Inc. | 37ff1b8e-a434-41c0-82e1-4583842921a5 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride ER | METFORMIN HYDROCHLORIDE | AvKARE | 1aa40000-877f-8ea4-e063-6394a90a0e31 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | Metformin hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Mullan Pharmaceutical Inc. | 082b4de9-e452-fe71-e063-6394a90ac863 | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 0230a3c3-34cf-478b-88c3-4d96e5300018 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | c72cfd1a-dce9-43a3-88e2-3cf1d9078b52 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 403349a1-ec19-8982-e063-6294a90aa060 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4be72741-4f6d-6689-e054-00144ff8d46c | 2025-09-22 | Boxed warning, Warnings, Adverse reactions | Metformin hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Coupler LLC | 3eeee3b7-188a-05a0-e063-6294a90a1853 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | 8c7835fa-3f68-4850-b1da-34893bafb485 | 2025-08-28 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3d450933-8d9d-27de-e063-6294a90ae6d9 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | f2318509-9a49-4c99-a08b-22381f17aacd | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3cbb802d-d493-255e-e063-6294a90a32f2 | 2025-08-19 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 53ba7031-be87-47a5-ade7-494c6c489cc6 | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 056072d8-6228-4914-831d-ee7c0661b742 | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e1ebb146-acfd-4301-a79c-f5bb243f8575 | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | bf918d78-3fb6-4d8d-b42d-538ea10bc3e4 | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e55ee270-5eb9-4848-8529-9af2a79669c0 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3ab4efb6-bd30-2583-e063-6294a90a415b | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 72dbc087-9a84-4126-bf54-c5254a8b129c | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.