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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018810
Company: THEPHARMANETWORK LLC

Products on NDA 018810

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THERMAZENE	SILVER SULFADIAZINE	1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018810

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.

Therapeutic Equivalents for NDA 018810

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	Yes	AB	018578	DR REDDYS LA
THERMAZENE	SILVER SULFADIAZINE	1%	CREAM;TOPICAL	Prescription	No	AB	018810	THEPHARMANETWORK LLC

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