Drugs@FDA: FDA-Approved Drugs
Company: FERRING PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DDAVP | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DDAVP | DESMOPRESSIN ACETATE | 0.015MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/30/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/22/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018938s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018938Orig1s035ltr.pdf | |
12/18/2015 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/22/2015 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/10/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/28/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/13/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/05/2015 | SUPPL-29 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017922Orig1s042,018938Orig1s029ltr.pdf | |
10/26/2007 | SUPPL-27 | 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-23 | 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-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr019,19955slr005ltr.pdf |
08/08/2002 | SUPPL-17 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18938slr017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018938_S017_DDAVP_AP.pdf |
10/31/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/13/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/24/1999 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/17/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
04/25/1995 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/13/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
01/11/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
05/12/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
04/22/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/03/1991 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/03/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
07/01/1988 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/25/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/07/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
12/20/1984 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/22/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018938s035lbl.pdf | |
11/05/2015 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf | |
11/05/2015 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf | |
10/26/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf | |
11/10/2005 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf |
DDAVP
INJECTABLE;INJECTION; 0.004MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DDAVP | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018938 | FERRING PHARMS INC |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091374 | AM REGENT |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204695 | SAGENT PHARMS INC |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204751 | SAGENT PHARMS INC |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091280 | SUN PHARM INDS LTD |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074888 | TEVA PHARMS USA |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210218 | UBI |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210223 | UBI |
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