Details for New Drug Application (NDA): 020649
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NDA 020649 describes EDEX, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the EDEX profile page.
The generic ingredient in EDEX 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 EDEX 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 020649
| Tradename: | EDEX |
| Applicant: | Endo Operations |
| Ingredient: | alprostadil |
| Patents: | 0 |
Pharmacology for NDA: 020649
| Mechanism of Action | Prostaglandin Receptor Agonists |
| Physiological Effect | Genitourinary Arterial Vasodilation Venous Vasodilation |
Medical Subject Heading (MeSH) Categories for 020649
Suppliers and Packaging for NDA: 020649
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDEX | alprostadil | INJECTABLE;INJECTION | 020649 | NDA | ENDO USA, Inc. | 52244-010 | 52244-010-02 | 2 BLISTER PACK in 1 CARTON (52244-010-02) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE |
| EDEX | alprostadil | INJECTABLE;INJECTION | 020649 | NDA | ENDO USA, Inc. | 52244-010 | 52244-010-06 | 6 BLISTER PACK in 1 CARTON (52244-010-06) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.005MG/VIAL | ||||
| Approval Date: | Jun 12, 1997 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.01MG/VIAL | ||||
| Approval Date: | Jun 12, 1997 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.02MG/VIAL | ||||
| Approval Date: | Jun 12, 1997 | TE: | AP | RLD: | Yes | ||||
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