Details for New Drug Application (NDA): 020357
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NDA 020357 describes GLUCOPHAGE, which is a drug marketed by Emd Serono Inc and is included in two NDAs. Additional details are available on the GLUCOPHAGE profile page.
The generic ingredient in GLUCOPHAGE is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
The generic ingredient in GLUCOPHAGE is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 020357
| Tradename: | GLUCOPHAGE |
| Applicant: | Emd Serono Inc |
| Ingredient: | metformin hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020357
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 3, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 3, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 5, 1998 | TE: | RLD: | Yes | |||||
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