FDA.reportPublic FDA data

Application 020475

Type
NDA
Sponsor
VALEANT INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETIN-A MICROTRETINOINGEL;TOPICAL0.1%YesYes
002RETIN-A MICROTRETINOINGEL;TOPICAL0.04%YesYes
003RETIN-A-MICROTRETINOINGEL;TOPICAL0.08%YesYes
004RETIN-A-MICROTRETINOINGEL;TOPICAL0.06%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5140Retin-A MICROTretinoinBausch Health US LLCNDACurrent
0187-5140Retin-A MICROTretinoinBausch Health US LLCNDACurrent
0187-5140Retin-A MICROTretinoinBausch Health Americas Inc.NDACurrent
0187-5140Retin-A MICROTretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-5144Retin-A MICROTretinoinBausch Health US LLCNDACurrent
0187-5144Retin-A MICROTretinoinBausch Health US LLCNDACurrent
0187-5144Retin-A MICROTretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-5144Retin-A MICROTretinoinBausch Health Americas Inc.NDACurrent
0187-5146Retin-A MICROTretinoinBausch Health US LLCNDACurrent
0187-5146Retin-A MICROTretinoinBausch Health US LLCNDACurrent
0187-5146Retin-A MICROTretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-5146Retin-A MICROTretinoinBausch Health Americas Inc.NDACurrent
0187-5148Retin-A MICROTretinoinBausch Health US LLCNDACurrent
0187-5148Retin-A MICROTretinoinBausch Health US LLCNDACurrent
0187-5148Retin-A MICROTretinoinValeant Pharmaceuticals North America LLCNDACurrent
0187-5148Retin-A MICROTretinoinBausch Health Americas Inc.NDACurrent
0378-8092TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8092TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8092TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8092TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8092TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8093TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8093TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8093TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8093TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8093TretinoinTretinoinMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
66530-259Tretinoin Gel MicrosphereTretinoinSpear Dermatology Products IncNDA AUTHORIZED GENERICCurrent
66530-260Tretinoin Gel MicrosphereTretinoinSpear Dermatology Products IncNDA AUTHORIZED GENERICCurrent
68682-513TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-513TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-513TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-514TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-514TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-514TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-515TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-515TretinoinTretinoinOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85992SUPPL 2026-05-21
85644SUPPL 2026-04-07
85643SUPPL 2026-04-07
83320SUPPL 2025-09-11
41387SUPPL2015-08-25
12619SUPPL2014-01-31
34688SUPPL2002-05-10
2578SUPPL2002-05-10
41386ORIG1997-02-07