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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020126
Company: MYLAN

Products on NDA 020126

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZONALON	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020126

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/1994	ORIG-1	Approval	Type 3 - New Dosage Form	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
12/20/2002	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20126slr006ltr.pdf
08/01/1996	SUPPL-4	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020126Orig1s004.pdf
06/29/1995	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/1994	SUPPL-2	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020126Orig1s002.pdf
05/01/1995	SUPPL-1	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020126Orig1s001.pdf

Labels for NDA 020126

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2002	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pdf

Therapeutic Equivalents for NDA 020126

ZONALON

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	No	AB	212357	AMNEAL
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	No	AB	215408	TEVA PHARMS
ZONALON	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	Yes	AB	020126	MYLAN

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