Details for New Drug Application (NDA): 075196
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NDA 075196 describes ALPROSTADIL, which is a drug marketed by Hikma and Meitheal and is included in two NDAs. It is available from one supplier. Additional details are available on the ALPROSTADIL profile page.
The generic ingredient in ALPROSTADIL 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 ALPROSTADIL 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 075196
| Tradename: | ALPROSTADIL |
| Applicant: | Meitheal |
| Ingredient: | alprostadil |
| Patents: | 0 |
Pharmacology for NDA: 075196
| Mechanism of Action | Prostaglandin Receptor Agonists |
| Physiological Effect | Genitourinary Arterial Vasodilation Venous Vasodilation |
Medical Subject Heading (MeSH) Categories for 075196
Suppliers and Packaging for NDA: 075196
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALPROSTADIL | alprostadil | INJECTABLE;INJECTION | 075196 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-206 | 71288-206-02 | 10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/ML | ||||
| Approval Date: | Apr 30, 1999 | TE: | AP | RLD: | No | ||||
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