Details for New Drug Application (NDA): 091345
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NDA 091345 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 four suppliers. 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 are twenty drug master file entries 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 are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 091345
| Tradename: | DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) |
| Applicant: | Zydus Pharms |
| Ingredient: | desmopressin acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091345
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | desmopressin acetate | SPRAY, METERED;NASAL | 091345 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-384 | 68382-384-01 | 5 mL in 1 BOTTLE, SPRAY (68382-384-01) |
| DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | desmopressin acetate | SPRAY, METERED;NASAL | 091345 | ANDA | Zydus Lifesciences Limited | 70771-1314 | 70771-1314-1 | 5 mL in 1 BOTTLE, SPRAY (70771-1314-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.01MG/SPRAY | ||||
| Approval Date: | Oct 3, 2017 | TE: | AB | RLD: | No | ||||
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