Details for New Drug Application (NDA): 210223
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NDA 210223 describes DESMOPRESSIN ACETATE, which is a drug marketed by Am Regent, Bedford, Dr Reddys, Gland, Gland Pharma Ltd, Hospira, Meitheal, Sagent Pharms Inc, Sun Pharm Inds Ltd, UBI, Sun Pharm Inds, Bausch, Abhai Llc, Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma, Ferring, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Natco Pharma Usa, Novast Labs, Apotex, Sun Pharm, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from twenty-two suppliers. Additional details are available on the DESMOPRESSIN ACETATE profile page.
The generic ingredient in DESMOPRESSIN ACETATE 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 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 210223
| Tradename: | DESMOPRESSIN ACETATE |
| Applicant: | Ubi |
| Ingredient: | desmopressin acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210223
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESMOPRESSIN ACETATE | desmopressin acetate | INJECTABLE;INJECTION | 210223 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-6200 | 39822-6200-2 | 10 VIAL in 1 CARTON (39822-6200-2) / 1 mL in 1 VIAL (39822-6200-1) |
| DESMOPRESSIN ACETATE | desmopressin acetate | INJECTABLE;INJECTION | 210223 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-6250 | 39822-6250-1 | 1 VIAL in 1 CARTON (39822-6250-1) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.004MG/ML | ||||
| Approval Date: | Sep 17, 2020 | TE: | AP | RLD: | No | ||||
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