Application 208999
- Type
- ANDA
- Sponsor
- SUNSHINE LAKE
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 |
|---|---|---|---|---|---|---|---|
| A208999-001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | ||
| A208999-002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | ||
| A208999-003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208999-002 | METFORMIN HYDROCHLORIDE | 850MG | TABLET / ORAL | 2018-10-12 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208999-003 | METFORMIN HYDROCHLORIDE | 1GM | TABLET / ORAL | 2018-10-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208999-001 | METFORMIN HYDROCHLORIDE | 500MG | TABLET / ORAL | 2018-10-12 | 8072bd15b7f6… |
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 | PD-Rx Pharmaceuticals, Inc. | 41408f64-d366-403e-9595-464ab25c6f97 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 68d0b1a6-c99e-42cf-afdf-b71ee73c4424 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9171d369-d35a-40e4-a9ad-26484e66fc5e | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 30658e19-8e6e-49aa-a007-e414224797c5 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1503bbe4-0ac5-479b-9900-d38e49236bf0 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | e22a8545-86a6-439e-a758-29c4d6ed8bfe | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Cardinal Health 107, LLC | 46cb7e3f-c739-433d-9dbe-427c2d95bef1 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Chartwell RX, LLC | 4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 13235d8e-ac3a-45b4-9c5d-9a9012951dfe | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 4ac6d01a-af26-44e7-ae2e-3618de0080aa | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | d5228e81-9c86-4781-b984-20feaa2ae779 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 5647230e-5bc6-1802-e063-6394a90a2724 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | fc466c46-abaa-4675-aef2-4b1a1adfd912 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 14f3091c-f243-4364-b433-727c7d4ef8d5 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 17050df5-9e95-4e1b-ac75-34add289b139 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Metformin hydrochloride METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE ER | METFORMIN HYDROCHLORIDE | Leading Pharma, LLC | 3dca884d-ec44-496f-9eeb-31fd8fa3f574 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | a944a167-e3ac-4084-af1c-22b48713471c | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 9eebed09-2562-4d21-b3b3-c06562fe3f99 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | MARKSANS PHARMA LIMITED | d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Metformin Hydrochloride METFORMIN HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48792-7861 | Metformin Hydrochloride | Metformin Hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7862 | Metformin Hydrochloride | Metformin Hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7863 | Metformin Hydrochloride | Metformin Hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |