Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019955
Company: FERRING PHARMS INC
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#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. |
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 |
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 |