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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019049
Company: BAUSCH

Products on NDA 019049

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETIN-A	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019049

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/1988	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
05/13/2016	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
01/08/2013	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
12/06/2002	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/20/2001	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/10/2002	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
01/25/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/23/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/10/2002	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
06/10/2002	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf
01/24/1992	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
07/03/1990	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/28/1990	SUPPL-3	Labeling		Label is not available on this site.
08/28/1990	SUPPL-2	Labeling		Label is not available on this site.
12/01/1989	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 019049

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2002	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf

Therapeutic Equivalents for NDA 019049

RETIN-A

CREAM;TOPICAL; 0.025%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVITA	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	020404	MYLAN PHARMS INC
RETIN-A	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	Yes	AB	019049	BAUSCH
TRETINOIN	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	218399	ALEMBIC
TRETINOIN	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	217831	ENCUBE
TRETINOIN	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	075264	PADAGIS US
TRETINOIN	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	215713	SUN PHARMA CANADA

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