Application 075967
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
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 |
|---|---|---|---|---|---|---|---|
| A075967-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | ||
| A075967-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | ||
| A075967-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 |
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 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075967-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2002-01-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075967-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2002-01-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075967-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2002-01-29 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075967-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075967-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075967-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075967-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075967-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075967-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075967-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075967-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075967-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075967-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075967-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075967-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075967-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075967-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075967-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075967-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075967-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075967-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075967-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075967-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075967-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075967-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075967-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075967-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075967-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075967-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075967-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075967-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075967-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075967-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075967-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075967-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075967-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075967-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075967-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075967-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075967-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075967-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075967-003 | AB | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075967-001 | AB | 1 | a67488948f0b… |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-471 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp. | ANDA | Current |
| 21695-472 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp. | ANDA | Current |
| 21695-473 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp. | ANDA | Current |
| 33261-145 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-157 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-0771 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0771 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0777 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51138-074 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Med-Health Pharma, LLC | ANDA | Current |
| 51138-075 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Med-Health Pharma, LLC | ANDA | Current |
| 51138-076 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Med-Health Pharma, LLC | ANDA | Current |
| 51655-549 | Metformin Hydrochloride | Metformin Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53808-0713 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0718 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0720 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 57664-397 | Metformin Hydrochloride | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-435 | Metformin Hydrochloride | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-474 | Metformin Hydrochloride | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-1397 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1397 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64725-0397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TYA Pharmaceuticals | ANDA | Current |
| 66267-493 | Metformin Hydrochloride | Metformin Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-493 | Metformin Hydrochloride | Metformin Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67296-0712 | Metformin Hydrochloride | Metformin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0712 | Metformin Hydrochloride | Metformin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0712 | Metformin Hydrochloride | Metformin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68788-0397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0435 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0474 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0034 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0237 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0435 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0606 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0994 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0994 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0592 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 75921-397 | Metformin Hydrochloride | metformin hydrochloride | Life Line Home Care Services, Inc. | ANDA | Current |