Details for New Drug Application (NDA): 208441
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The generic ingredient in AMBRISENTAN is ambrisentan. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.
Summary for 208441
Tradename: | AMBRISENTAN |
Applicant: | Mylan |
Ingredient: | ambrisentan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208441
Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 208441
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMBRISENTAN | ambrisentan | TABLET;ORAL | 208441 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4270 | 0378-4270-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4270-93) |
AMBRISENTAN | ambrisentan | TABLET;ORAL | 208441 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4271 | 0378-4271-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4271-93) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 28, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 28, 2019 | TE: | AB | RLD: | No |
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