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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019955
Company: FERRING PHARMS INC

Other Important Information from FDA

Products on NDA 019955

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019955

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#page=33 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#page=28 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.

Labels for NDA 019955

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#page=33
11/10/2005	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf#page=28

Therapeutic Equivalents for NDA 019955

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	077414	APOTEX INC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Prescription	No	AB	213095	AUROBINDO PHARMA
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	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	077414	APOTEX INC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	No	AB	213095	AUROBINDO PHARMA
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	208357	NOVAST LABS

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