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Details for New Drug Application (NDA): 020379
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NDA 020379 describes CAVERJECT, which is a drug marketed by Pfizer and Pharmacia And Upjohn and is included in three NDAs. It is available from one supplier. Additional details are available on the CAVERJECT profile page.
The generic ingredient in CAVERJECT is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.
The generic ingredient in CAVERJECT is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.
Summary for 020379
| Tradename: | CAVERJECT |
| Applicant: | Pharmacia And Upjohn |
| Ingredient: | alprostadil |
| Patents: | 0 |
Pharmacology for NDA: 020379
| Mechanism of Action | Prostaglandin Receptor Agonists |
| Physiological Effect | Genitourinary Arterial Vasodilation Venous Vasodilation |
Medical Subject Heading (MeSH) Categories for 020379
Suppliers and Packaging for NDA: 020379
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379 | NDA | Pharmacia and Upjohn Company LLC | 0009-3701 | 0009-3701-05 | 6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3701-05) > 1 mL in 1 VIAL, SINGLE-DOSE (0009-3701-08) |
| CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379 | NDA | Pharmacia and Upjohn Company LLC | 0009-7686 | 0009-7686-04 | 6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-7686-04) > 1 mL in 1 VIAL, SINGLE-DOSE (0009-7686-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.01MG/VIAL | ||||
| Approval Date: | Jul 6, 1995 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.02MG/VIAL | ||||
| Approval Date: | Jul 6, 1995 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.005MG/VIAL | ||||
| Approval Date: | Jun 27, 1996 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020379
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-003 | Jun 27, 1996 | Start Trial | Start Trial |
| Pharmacia And Upjohn | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-004 | May 19, 1997 | Start Trial | Start Trial |
| Pharmacia And Upjohn | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-002 | Jul 6, 1995 | Start Trial | Start Trial |
| Pharmacia And Upjohn | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-002 | Jul 6, 1995 | Start Trial | Start Trial |
| Pharmacia And Upjohn | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-001 | Jul 6, 1995 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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