Details for New Drug Application (NDA): 040235
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NDA 040235 describes PHENTOLAMINE MESYLATE, which is a drug marketed by Hikma and Precision Dose Inc and is included in two NDAs. It is available from three suppliers. Additional details are available on the PHENTOLAMINE MESYLATE profile page.
The generic ingredient in PHENTOLAMINE MESYLATE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.
The generic ingredient in PHENTOLAMINE MESYLATE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.
Summary for 040235
| Tradename: | PHENTOLAMINE MESYLATE |
| Applicant: | Hikma |
| Ingredient: | phentolamine mesylate |
| Patents: | 0 |
Pharmacology for NDA: 040235
| Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for 040235
Suppliers and Packaging for NDA: 040235
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENTOLAMINE MESYLATE | phentolamine mesylate | INJECTABLE;INJECTION | 040235 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9564 | 0143-9564-01 | 1 VIAL in 1 BOX (0143-9564-01) / 1 mL in 1 VIAL |
| PHENTOLAMINE MESYLATE | phentolamine mesylate | INJECTABLE;INJECTION | 040235 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9564 | 0143-9564-10 | 10 VIAL in 1 BOX (0143-9564-10) / 1 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/VIAL | ||||
| Approval Date: | Mar 11, 1998 | TE: | AP | RLD: | No | ||||
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