Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018578
Company: DR REDDYS LA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SSD SILVER SULFADIAZINE 1% CREAM;TOPICAL Prescription AB No No
SSD AF SILVER SULFADIAZINE 1% CREAM;TOPICAL 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
02/25/1982 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
04/21/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/24/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/12/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1995 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/03/1990 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/11/1990 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/15/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/11/1990 SUPPL-6 Labeling

Label is not available on this site.

12/10/1985 SUPPL-5 Labeling

Label is not available on this site.

03/16/1984 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/19/1983 SUPPL-3 Labeling

Label is not available on this site.

05/12/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

SSD

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

SSD AF

There are no Therapeutic Equivalents.

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