Details for New Drug Application (NDA): 021202
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The generic ingredient in GLUCOPHAGE XR 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 021202
Tradename: | GLUCOPHAGE XR |
Applicant: | Emd Serono Inc |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021202
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 13, 2000 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Apr 11, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 021202
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Emd Serono Inc | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-001 | Oct 13, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Emd Serono Inc | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-004 | Apr 11, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Emd Serono Inc | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-004 | Apr 11, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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