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 | A-S Medication Solutions | a4679179-af2d-4c84-a1c8-ab0870a4585d | 2023-10-18 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | VGYAAN Pharmaceuticals LLC | 129ff158-097f-401a-8924-d9258465c1f3 | 2023-09-22 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | d60139c2-fd35-4ab4-af7e-7410481edc2e | 2023-09-18 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 1b9b6db9-1bac-4252-a03c-18dc0271f05f | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 88af3365-1145-45a1-ab0f-1c794f0c13db | 2023-05-24 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride ER | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1ebaab3a-3d62-4c36-853f-c8784993eafb | 2023-04-14 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 86627ff4-da1c-429d-991b-88e97f6967d6 | 2023-04-11 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 8ce6b615-2abd-4a5b-997b-11aa1aec142d | 2023-03-28 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | f86bda10-8b25-4125-8bb1-1b5917969ff0 | 2023-03-21 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | a57e2890-d83b-488c-b221-2e8f8a78ed16 | 2023-03-15 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 76879512-3ab4-4acf-92e6-bba0fb75dd0e | 2023-03-10 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | a59327bd-a3ba-417b-9e91-4cd3a941e640 | 2023-03-10 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | a79d2674-071f-4641-9b11-406e02c5530a | 2023-03-10 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 93b0878d-b039-4479-8315-6dabf7e70611 | 2023-02-23 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride Extended-Release 500mg | METFORMIN HYDROCHLORIDE | Calvin Scott & Co., Inc. | e9cd0d23-56eb-40dd-abf4-9e681ec220f5 | 2023-02-07 | Warnings | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 623b3bc6-1b07-4a04-bc7a-7fc695adf063 | 2023-01-18 | Boxed warning, Warnings, Adverse reactions | Metformin hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 34aa1761-d16f-4bfc-b7fa-bf1b0387e8a3 | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | d0bee456-c8cd-46a1-acb3-5313a8cddd30 | 2022-11-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 474e2900-43bf-4ebe-9d29-4a7adb8a9429 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 6b8824c0-ece0-4b15-ba71-e893d6d2bfdf | 2022-07-15 | 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.