FDA Approval Activities for this Drug…

DDAVP (desmopressin acetate) Injection, 4 µg/mL Aventis Pharmaceutical Products NDA 18-938/S-017 Desmopressin Acetate Injection,4 mcg/mL (packaged in 1 mL ampules), Abbott ANDA 75-220 8/28/00 10/31/00 Desmopressin Acetate Injection,4 mcg/mL (packaged in 10 mL vials), Bedford ANDA 74-575 2/18/00 2/24/00 Desmopressin Acetate Injection (Preservative-free),4 mcg/mL (packaged in 1 mL ampules), Bedford ANDA 74-574 2/18/00 2/24/00 Desmopressin Acetate Nasal Solution, 0.01% Ferring 21-333/S1 9/4/03 9/25/03 9/25/03 Desmopressin Acetate Nasal Solution, 0.01% Bausch & Lomb ANDA 74-830 1/25/99 1/25/99 4/22/03 Desmopressin Acetate Nasal Spray, Ferring NDA 21-333 Stimate (desmopressin acetate) Nasal Spray, 1.5 mg/mL Aventis Behring NDA 20-355/S-004 DESMOPRESSIN ACETATE Injection 0.004MG/ML DESMOPRESSIN ACETATE Abbott 018938 DESMOPRESSIN ACETATE Injection 0.004MG/ML DDAVP AVENTIS 018938 DESMOPRESSIN ACETATE Injection 0.015MG/ML DDAVP AVENTIS 074574 DESMOPRESSIN ACETATE Injection 0.004MG/ML DESMOPRESSIN ACETATE PRESERVATIVE FREE Bedford 074575 DESMOPRESSIN ACETATE Injection 0.004MG/ML DESMOPRESSIN ACETATE Bedford 074888 DESMOPRESSIN ACETATE Injection 0.004MG/ML DESMOPRESSIN ACETATE Gensia Sicor 017922 DESMOPRESSIN ACETATE Solution; Nasal 0.01% DDAVP AVENTIS 017922 DESMOPRESSIN ACETATE Spray, Metered; Nasal 0.01MG/SPRAY DDAVP (NEEDS NO REFRIGERATION) AVENTIS 020355 DESMOPRESSIN ACETATE Spray, Metered; Nasal 0.15MG/SPRAY STIMATE AVENTIS BEHRING 074830 DESMOPRESSIN ACETATE Spray, Metered; Nasal 0.01MG/SPRAY DESMOPRESSIN ACETATE BAUSCH AND LOMB 021333 DESMOPRESSIN ACETATE Spray, Metered; Nasal 0.01MG/SPRAY MINIRIN FERRING 019955 DESMOPRESSIN ACETATE Tablet; 0.1MG DDAVP AVENTIS 019955 DESMOPRESSIN ACETATE Tablet; 0.2MG DDAVP AVENTIS DDAVP (desmopressin acetate) Nasal Spray, Injection & Tablets, Aventis | Desmopressin Acetate Nasal Solution, Apotex Inc., Tentative Approval | Desmopressin Acetate Nasal Solution, Apotex Corp., Approval

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