Details for New Drug Application (NDA): 204060
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NDA 204060 describes FOSAMPRENAVIR CALCIUM, which is a drug marketed by Mylan and Sun Pharm and is included in two NDAs. It is available from two suppliers. Additional details are available on the FOSAMPRENAVIR CALCIUM profile page.
The generic ingredient in FOSAMPRENAVIR CALCIUM is fosamprenavir calcium. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.
The generic ingredient in FOSAMPRENAVIR CALCIUM is fosamprenavir calcium. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.
Summary for 204060
| Tradename: | FOSAMPRENAVIR CALCIUM |
| Applicant: | Mylan |
| Ingredient: | fosamprenavir calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204060
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSAMPRENAVIR CALCIUM | fosamprenavir calcium | TABLET;ORAL | 204060 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3520 | 0378-3520-91 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 700MG BASE | ||||
| Approval Date: | Apr 15, 2016 | TE: | AB | RLD: | No | ||||
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