Details for New Drug Application (NDA): 216922
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NDA 216922 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 216922
| Tradename: | DESMOPRESSIN ACETATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | desmopressin acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216922
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESMOPRESSIN ACETATE | desmopressin acetate | INJECTABLE;INJECTION | 216922 | ANDA | Fresenius Kabi USA, LLC | 65219-293 | 65219-293-01 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-293-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-293-00) |
| DESMOPRESSIN ACETATE | desmopressin acetate | INJECTABLE;INJECTION | 216922 | ANDA | Gland Pharma Limited | 68083-550 | 68083-550-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-550-10) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-550-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.004MG/ML | ||||
| Approval Date: | Nov 16, 2022 | TE: | AP | RLD: | No | ||||
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