Details for New Drug Application (NDA): 019856
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The generic ingredient in SINEMET CR is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 019856
Tradename: | SINEMET CR |
Applicant: | Organon Llc |
Ingredient: | carbidopa; levodopa |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 30, 1991 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 24, 1992 | TE: | RLD: | Yes |
Expired US Patents for NDA 019856
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | ⤷ Sign Up | ⤷ Sign Up |
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