Details for New Drug Application (NDA): 020379
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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: | Pfizer |
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 & 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 & 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 |
---|---|---|---|---|---|---|---|
Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-001 | Jul 6, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-002 | Jul 6, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-003 | Jun 27, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-004 | May 19, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-002 | Jul 6, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-001 | Jul 6, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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