Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019955
Company: FERRING PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DDAVP DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription AB Yes No
DDAVP DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription AB Yes 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
09/06/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/26/2007 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017922s038, 018938s027, 019955s013ltr.pdf
11/10/2005 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017922s034,018938s023,019955s010ltr.pdf
11/12/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr019,19955slr005ltr.pdf
10/31/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1998 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/26/2007 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf
11/10/2005 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf

DDAVP

TABLET;ORAL; 0.1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DDAVP DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription Yes AB 019955 FERRING PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 210371 ABHAI LLC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 076470 ACTAVIS LABS FL INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 077414 APOTEX INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 201831 GLENMARK PHARMS LTD
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 207880 HERITAGE PHARMA
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 077122 IMPAX LABS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 200653 MYLAN
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.1MG TABLET;ORAL Prescription No AB 208357 NOVAST LABS

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DDAVP DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription Yes AB 019955 FERRING PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 210371 ABHAI LLC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 076470 ACTAVIS LABS FL INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 077414 APOTEX INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 201831 GLENMARK PHARMS LTD
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 207880 HERITAGE PHARMA
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 077122 IMPAX LABS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 200653 MYLAN
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.2MG TABLET;ORAL Prescription No AB 208357 NOVAST LABS

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