Details for New Drug Application (NDA): 210715
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The generic ingredient in AMBRISENTAN is ambrisentan. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.
Summary for 210715
Tradename: | AMBRISENTAN |
Applicant: | Cipla |
Ingredient: | ambrisentan |
Patents: | 0 |
Pharmacology for NDA: 210715
Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 210715
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMBRISENTAN | ambrisentan | TABLET;ORAL | 210715 | ANDA | Cipla USA Inc. | 69097-386 | 69097-386-02 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-386-02) |
AMBRISENTAN | ambrisentan | TABLET;ORAL | 210715 | ANDA | Cipla USA Inc. | 69097-386 | 69097-386-19 | 1 BLISTER PACK in 1 CARTON (69097-386-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 26, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 26, 2019 | TE: | AB | RLD: | No |
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