Details for New Drug Application (NDA): 207686
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NDA 207686 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 207686
| Tradename: | PHENTOLAMINE MESYLATE |
| Applicant: | Precision Dose Inc |
| Ingredient: | phentolamine mesylate |
| Patents: | 0 |
Pharmacology for NDA: 207686
| Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for 207686
Suppliers and Packaging for NDA: 207686
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENTOLAMINE MESYLATE | phentolamine mesylate | INJECTABLE;INJECTION | 207686 | ANDA | TAGI Pharma, Inc. | 51224-012 | 51224-012-10 | 10 CARTON in 1 TRAY (51224-012-10) / 1 VIAL in 1 CARTON (51224-012-20) / 1 INJECTION in 1 VIAL |
| PHENTOLAMINE MESYLATE | phentolamine mesylate | INJECTABLE;INJECTION | 207686 | ANDA | TAGI Pharma, Inc. | 51224-012 | 51224-012-20 | 1 VIAL in 1 CARTON (51224-012-20) / 1 INJECTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/VIAL | ||||
| Approval Date: | Jul 14, 2017 | TE: | AP | RLD: | No | ||||
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