Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090785
Company: PADAGIS ISRAEL

Products on ANDA 090785

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2010	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090785s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090785Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
11/30/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090785

CLINDAMYCIN PHOSPHATE

AEROSOL, FOAM;TOPICAL; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM;TOPICAL	Prescription	No	AT	210778	GLENMARK PHARMS LTD
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM;TOPICAL	Prescription	No	AT	090785	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM;TOPICAL	Prescription	No	AT	210004	TARO