Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074830
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/25/1999 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74830ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-830_Desmopressin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

04/02/2015 SUPPL-15 Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/25/2008 SUPPL-13 Labeling

Label is not available on this site.

09/21/2004 SUPPL-8 Labeling

Label is not available on this site.

10/25/1999 SUPPL-4 Labeling

Label is not available on this site.

04/28/2000 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/13/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DESMOPRESSIN ACETATE

SPRAY, METERED;NASAL; 0.01MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DDAVP (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 017922 FERRING PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 074830 BAUSCH AND LOMB
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076703 APOTEX INC
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 078271 SUN PHARM
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 091345 ZYDUS PHARMS
MINIRIN DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 021333 FERRING

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