Details for New Drug Application (NDA): 078321
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NDA 078321 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Bionpharma, Saptalis Pharms, Vistapharm Llc, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Barr, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Harman Finochem, Impax Labs, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Medicap Labs, Micro Labs, Mpp Pharma, Mylan Pharms Inc, Nostrum Pharms Llc, Novast Labs, Pharmobedient, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Regcon Holdings, Rk Pharma, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Utopic Pharms, Watson Labs Inc, Yichang Humanwell, Zydus Lifesciences, Aarxion Anda Hlding, Alkem, Anda Repository, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Granules India, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Mylan, Provident Pharm, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, and Zydus Pharms Usa, and is included in one hundred and four NDAs. It is available from eighty-four suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 078321
| Tradename: | METFORMIN HYDROCHLORIDE |
| Applicant: | Cspc Ouyi |
| Ingredient: | metformin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078321
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 078321 | ANDA | Calvin Scott & Co., Inc. | 17224-311 | 17224-311-28 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-311-28) |
| METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 078321 | ANDA | AvPAK | 50268-550 | 50268-550-15 | 50 BLISTER PACK in 1 BOX (50268-550-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-550-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 17, 2008 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
| Approval Date: | Apr 17, 2008 | TE: | AB | RLD: | No | ||||
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