Details for New Drug Application (NDA): 076703
NDA 076703 describes DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), which is a drug marketed by Apotex, Sun Pharm, and Zydus Pharms, and is included in three NDAs. It is available from one supplier. Additional details are available on the DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) profile page.
The generic ingredient in DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) is desmopressin acetate. There is one drug master file entry for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
The generic ingredient in DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) is desmopressin acetate. There is one drug master file entry for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 076703
| Tradename: | DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) |
| Applicant: | Apotex |
| Ingredient: | desmopressin acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076703
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | desmopressin acetate | SPRAY, METERED;NASAL | 076703 | ANDA | Apotex Corp. | 60505-0815 | 60505-0815-0 | 1 BOTTLE, SPRAY in 1 CARTON (60505-0815-0) / 50 SPRAY in 1 BOTTLE, SPRAY |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.01MG/SPRAY | ||||
| Approval Date: | Jan 27, 2005 | TE: | AB | RLD: | No | ||||
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