Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077414
Company: APOTEX INC
Company: APOTEX INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.1MG | TABLET;ORAL | Prescription | AB | No | No |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.2MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/07/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/23/2015 | SUPPL-8 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/077414Orig1S008LABL.pdf |
09/03/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
DESMOPRESSIN ACETATE
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 |