Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017381
Company: KING PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SILVADENE SILVER SULFADIAZINE 1% CREAM;TOPICAL 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
11/26/1973 ORIG-1 Approval Type 2 - New Active Ingredient 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
08/01/2016 SUPPL-53 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017381s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017381Orig1s015ltr.pdf
04/30/2015 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/06/2013 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017381s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017381Orig1s050ltr.pdf
11/13/2012 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

01/29/2004 SUPPL-41 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17381slr041ltr.pdf
09/27/2001 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/04/1993 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/07/1992 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1992 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1991 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1991 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/05/1992 SUPPL-34 Labeling

Label is not available on this site.

11/14/1988 SUPPL-32 Labeling

Label is not available on this site.

10/29/1987 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/1986 SUPPL-30 Labeling

Label is not available on this site.

11/15/1985 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/12/1984 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/31/1984 SUPPL-27 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/06/1982 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/06/1982 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/10/1982 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1982 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/15/1982 SUPPL-21 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/19/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/26/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1979 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1979 SUPPL-15 Labeling

Label is not available on this site.

07/06/1979 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/17/1979 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1978 SUPPL-11 Labeling

Label is not available on this site.

09/28/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1977 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1977 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/1977 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/24/1977 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/11/1974 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
08/01/2016 SUPPL-53 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017381s053lbl.pdf
08/01/2016 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017381s053lbl.pdf
03/06/2013 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017381s050lbl.pdf

SILVADENE

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SILVADENE SILVER SULFADIAZINE 1% CREAM;TOPICAL Prescription Yes AB 017381 KING PHARMS LLC
SSD SILVER SULFADIAZINE 1% CREAM;TOPICAL Prescription No AB 018578 DR REDDYS LA
THERMAZENE SILVER SULFADIAZINE 1% CREAM;TOPICAL Prescription No AB 018810 THEPHARMANETWORK LLC

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