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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 074888


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NDA 074888 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.
Summary for 074888
Tradename:DESMOPRESSIN ACETATE
Applicant:Meitheal
Ingredient:desmopressin acetate
Patents:0
Suppliers and Packaging for NDA: 074888
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESMOPRESSIN ACETATE desmopressin acetate INJECTABLE;INJECTION 074888 ANDA Meitheal Pharmaceuticals Inc. 71288-440 71288-440-02 10 VIAL in 1 CARTON (71288-440-02) / 1 mL in 1 VIAL (71288-440-01)
DESMOPRESSIN ACETATE desmopressin acetate INJECTABLE;INJECTION 074888 ANDA Meitheal Pharmaceuticals Inc. 71288-441 71288-441-10 1 VIAL in 1 CARTON (71288-441-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.004MG/ML
Approval Date:Oct 15, 1997TE:APRLD:No

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