Suppliers and packagers for generic pharmaceutical drug: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
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DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211563 | ANDA | Ascend Laboratories, LLC | 67877-619-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-619-05) | 2026-04-06 |
| Alkem Labs Ltd | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211563 | ANDA | Ascend Laboratories, LLC | 67877-619-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-619-30) | 2026-04-06 |
| Alkem Labs Ltd | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211563 | ANDA | Ascend Laboratories, LLC | 67877-620-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-620-30) | 2026-04-06 |
| Alkem Labs Ltd | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211563 | ANDA | Ascend Laboratories, LLC | 67877-620-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-620-60) | 2026-04-06 |
| Alkem Labs Ltd | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211563 | ANDA | Ascend Laboratories, LLC | 67877-620-90 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-620-90) | 2026-04-06 |
| Alkem Labs Ltd | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211563 | ANDA | Ascend Laboratories, LLC | 67877-621-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-621-05) | 2026-04-06 |
| Alkem Labs Ltd | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211563 | ANDA | Ascend Laboratories, LLC | 67877-621-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-621-30) | 2026-04-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
