Details for New Drug Application (NDA): 090999
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NDA 090999 describes APREPITANT, which is a drug marketed by Glenmark Pharms Sa, Sandoz, and Torrent, and is included in three NDAs. It is available from three suppliers. Additional details are available on the APREPITANT profile page.
The generic ingredient in APREPITANT is aprepitant. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aprepitant profile page.
The generic ingredient in APREPITANT is aprepitant. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aprepitant profile page.
Summary for 090999
| Tradename: | APREPITANT |
| Applicant: | Sandoz |
| Ingredient: | aprepitant |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090999
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APREPITANT | aprepitant | CAPSULE;ORAL | 090999 | ANDA | Sandoz Inc | 0781-2321 | 0781-2321-06 | 1 BLISTER PACK in 1 CARTON (0781-2321-06) / 1 CAPSULE in 1 BLISTER PACK |
| APREPITANT | aprepitant | CAPSULE;ORAL | 090999 | ANDA | Sandoz Inc | 0781-2321 | 0781-2321-51 | 5 BLISTER PACK in 1 CARTON (0781-2321-51) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
| Approval Date: | Sep 24, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 80MG | ||||
| Approval Date: | Sep 24, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 125MG | ||||
| Approval Date: | Sep 24, 2012 | TE: | AB | RLD: | No | ||||
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