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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075502
Company: FOUGERA PHARMS

Products on ANDA 075502

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075502

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2001	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75502ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-502_Clotrimazole.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/06/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
07/06/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/11/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/11/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
06/26/2003	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075502

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

CREAM;TOPICAL; EQ 0.05% BASE;1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	076002	ACTAVIS MID ATLANTIC
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	075502	FOUGERA PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	202894	GLENMARK PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	075673	TARO

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