Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018810
Company: THEPHARMANETWORK LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THERMAZENE SILVER SULFADIAZINE 1% CREAM;TOPICAL 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
12/23/1985 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2016 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

11/27/2012 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/27/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1990 SUPPL-8 Labeling

Label is not available on this site.

10/24/1989 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/30/1989 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/12/1989 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1987 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/04/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1986 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

THERMAZENE

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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