Details for New Drug Application (NDA): 018482
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The generic ingredient in PROCARDIA is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 018482
Tradename: | PROCARDIA |
Applicant: | Pfizer |
Ingredient: | nifedipine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 018482
Suppliers and Packaging for NDA: 018482
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROCARDIA | nifedipine | CAPSULE;ORAL | 018482 | NDA AUTHORIZED GENERIC | Greenstone LLC | 59762-1004 | 59762-1004-1 | 100 CAPSULE in 1 BOTTLE (59762-1004-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 24, 1986 | TE: | RLD: | Yes |
Expired US Patents for NDA 018482
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | PROCARDIA | nifedipine | CAPSULE;ORAL | 018482-002 | Jul 24, 1986 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | PROCARDIA | nifedipine | CAPSULE;ORAL | 018482-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | PROCARDIA | nifedipine | CAPSULE;ORAL | 018482-002 | Jul 24, 1986 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | PROCARDIA | nifedipine | CAPSULE;ORAL | 018482-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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