Application 076413
- Type
- ANDA
- Sponsor
- RANBAXY LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076413-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 |
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 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076413-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE / ORAL | 2004-06-18 | f41ea6bd6efb… |
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 | MARKSANS PHARMA LIMITED | d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE TABLET | Granules India Ltd | 8cd5555c-f6b2-28d8-e053-2a95a90a5f1e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 552ad61d-bafd-478d-e063-6294a90a02f9 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | 3d6f397b-e909-bee9-e063-6294a90aba17 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Viona Pharmaceuticals Inc | 85027e6c-d35b-49eb-a234-dd71aa77aee0 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS | AiPing Pharmaceutical, Inc. | 96c8a89d-99db-24b1-e053-2a95a90ac2b8 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 41a8bb80-7b0b-476c-8134-5d161c3239c8 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 8d4b8620-5e99-4d12-b4f2-e9967b627b57 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Major Pharmaceuticals | 5e783025-bf6d-465e-bf58-bcd253afad2c | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 4182bcf0-1f9a-4f3a-9428-86b5d757954f | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c3 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 14450912-54b5-4fc3-ba65-77ece864b2e7 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 902d1bc4-3f1f-4a1a-86d7-cf98c56a3684 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 33550b88-d4bb-4ce6-a7db-07c966f6984f | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 14238afd-200d-4a05-b731-647c43cecbc3 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 104b5f5b-cc83-450d-82ec-1fd20c4f7119 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 11d52559-bfde-4c2a-9602-f18fb3187617 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN | Mylan Pharmaceuticals Inc. | 7e41818c-60e9-4bcf-9586-7bb8d33d5e89 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | f4fc759a-057e-4b5d-b8ab-13bc5eeb24e4 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 400ff9dc-9789-44ac-afb5-730b632a1667 | 2026-06-12 | 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.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8908 | ORIG | 2004-06-21 |