Details for New Drug Application (NDA): 018484
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NDA 018484 describes PROSTIN VR PEDIATRIC, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. Additional details are available on the PROSTIN VR PEDIATRIC profile page.
The generic ingredient in PROSTIN VR PEDIATRIC 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 PROSTIN VR PEDIATRIC 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 018484
| Tradename: | PROSTIN VR PEDIATRIC |
| Applicant: | Pfizer |
| Ingredient: | alprostadil |
| Patents: | 0 |
Pharmacology for NDA: 018484
| Mechanism of Action | Prostaglandin Receptor Agonists |
| Physiological Effect | Genitourinary Arterial Vasodilation Venous Vasodilation |
Medical Subject Heading (MeSH) Categories for 018484
Suppliers and Packaging for NDA: 018484
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROSTIN VR PEDIATRIC | alprostadil | INJECTABLE;INJECTION | 018484 | NDA | Pharmacia & Upjohn Company LLC | 0009-0215 | 0009-0215-05 | 5 AMPULE in 1 PACKAGE (0009-0215-05) / 1 mL in 1 AMPULE (0009-0215-01) |
| PROSTIN VR PEDIATRIC | alprostadil | INJECTABLE;INJECTION | 018484 | NDA | Pharmacia and Upjohn Company LLC | 0009-3169 | 0009-3169-06 | 5 AMPULE in 1 PACKAGE (0009-3169-06) / 1 mL in 1 AMPULE (0009-3169-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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