Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074888
Company: MEITHEAL
Company: MEITHEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
10/15/1997 | 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 |
---|---|---|---|---|---|
08/28/2024 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/25/2019 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
07/25/2019 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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03/27/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
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03/25/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
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08/10/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DESMOPRESSIN ACETATE
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 | 215961 | DR REDDYS |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216904 | GLAND |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216922 | GLAND PHARMA LTD |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074888 | MEITHEAL |
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 | 210218 | UBI |
DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210223 | UBI |