Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075213
Company: PADAGIS US

Products on ANDA 075213

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075213

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/24/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75213_Tretinoin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75213ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75213_Tretinoin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/20/2007	SUPPL-26	Labeling		Label is not available on this site.
02/21/2007	SUPPL-24	Labeling		Label is not available on this site.
10/24/2001	SUPPL-15	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
10/24/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
10/24/2001	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
01/23/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
08/01/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
08/01/2000	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
01/23/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
01/23/2001	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
02/29/2000	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
12/23/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075213

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/24/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75213_Tretinoin_prntlbl.pdf

Therapeutic Equivalents for ANDA 075213

TRETINOIN

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETIN-A	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	017340	VALEANT PHARMS NORTH
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	No	AB	075213	PADAGIS US
TRETINOIN	TRETINOIN	0.1%	CREAM;TOPICAL	Prescription	No	AB	211645	TARO