Details for New Drug Application (NDA): 019684
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NDA 019684 describes PROCARDIA XL, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the PROCARDIA XL profile page.
The generic ingredient in PROCARDIA XL is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
The generic ingredient in PROCARDIA XL is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 019684
| Tradename: | PROCARDIA XL |
| Applicant: | Pfizer |
| Ingredient: | nifedipine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019684
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 019684
Suppliers and Packaging for NDA: 019684
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-2650 | 0069-2650-41 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0069-2650-41) |
| PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-2650 | 0069-2650-66 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-2650-66) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Sep 6, 1989 | TE: | AB2 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Sep 6, 1989 | TE: | AB2 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 90MG | ||||
| Approval Date: | Sep 6, 1989 | TE: | AB2 | RLD: | Yes | ||||
Expired US Patents for NDA 019684
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-002 | Sep 6, 1989 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-002 | Sep 6, 1989 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-001 | Sep 6, 1989 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-003 | Sep 6, 1989 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-001 | Sep 6, 1989 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | PROCARDIA XL | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 019684-001 | Sep 6, 1989 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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