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Details for New Drug Application (NDA): 020336
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NDA 020336 describes DYNACIRC CR, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. Additional details are available on the DYNACIRC CR profile page.
The generic ingredient in DYNACIRC CR is isradipine. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isradipine profile page.
The generic ingredient in DYNACIRC CR is isradipine. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isradipine profile page.
Summary for 020336
| Tradename: | DYNACIRC CR |
| Applicant: | Glaxosmithkline Llc |
| Ingredient: | isradipine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 020336
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Jun 1, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Jun 1, 1994 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020336
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-002 | Jun 1, 1994 | Start Trial | Start Trial |
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-002 | Jun 1, 1994 | Start Trial | Start Trial |
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-001 | Jun 1, 1994 | Start Trial | Start Trial |
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-002 | Jun 1, 1994 | Start Trial | Start Trial |
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-001 | Jun 1, 1994 | Start Trial | Start Trial |
| Glaxosmithkline Llc | DYNACIRC CR | isradipine | TABLET, EXTENDED RELEASE;ORAL | 020336-002 | Jun 1, 1994 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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