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 |
---|---|---|---|---|---|
07/21/2022 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018938Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018938Orig1s039ltr.pdf | |
03/22/2018 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
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11/05/2015 | SUPPL-29 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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10/26/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
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11/10/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
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11/12/2003 | SUPPL-19 | Labeling |
Label is not available on this site. |
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08/08/2002 | SUPPL-17 | Labeling |
Label is not available on this site. |
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08/17/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
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03/13/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/11/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
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05/12/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
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04/03/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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11/07/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
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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 |
---|---|---|---|---|---|
07/21/2022 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018938Orig1s039lbl.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 | 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 |