tretinoin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
retinol derivatives 2722 302-79-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tretinoin potassium
  • trans-Retinoic acid
  • tretinoin sodium
  • retinoic acid
  • tretinoin
An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).
  • Molecular weight: 300.44
  • Formula: C20H28O2
  • CLOGP: 6.74
  • LIPINSKI: 1
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -4.80
  • ROTB: 5

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.70 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Oct. 20, 1971 FDA VALEANT INTL

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Differentiation syndrome 600.18 16.69 104 6423 829 50597768
Idiopathic intracranial hypertension 117.50 16.69 32 6495 2317 50596280
Blepharospasm 110.30 16.69 32 6495 2916 50595681
Product use in unapproved indication 109.47 16.69 102 6425 115717 50482880
Intracranial pressure increased 86.68 16.69 29 6498 4223 50594374
Leukaemia recurrent 76.54 16.69 20 6507 1234 50597363
Taste disorder 74.39 16.69 31 6496 8293 50590304
Epilepsy 49.01 16.69 32 6495 21535 50577062
Haematopoietic neoplasm 42.99 16.69 7 6520 36 50598561
Polyarteritis nodosa 35.68 16.69 8 6519 257 50598340
Lower respiratory tract infection fungal 34.83 16.69 8 6519 287 50598310
Migraine 33.82 16.69 45 6482 75235 50523362
Dysphoria 33.53 16.69 15 6512 4759 50593838
Dry skin 33.13 16.69 34 6493 43157 50555440
Hypoaesthesia 33.04 16.69 59 6468 127198 50471399
Haemorrhagic diathesis 32.92 16.69 14 6513 3934 50594663
Skin warm 30.48 16.69 14 6513 4721 50593876
Chromosomal deletion 29.65 16.69 5 6522 33 50598564
Disseminated intravascular coagulation 28.52 16.69 21 6506 17114 50581483
Myelodysplastic syndrome 28.52 16.69 20 6507 15112 50583485
Gastrooesophageal reflux disease 27.37 16.69 41 6486 76387 50522210
Appetite disorder 27.07 16.69 14 6513 6100 50592497
Chloroma 26.41 16.69 6 6521 205 50598392
Arthritis infective 25.38 16.69 13 6514 5556 50593041
Neutropenic sepsis 25.05 16.69 18 6509 14129 50584468
Xerosis 24.20 16.69 7 6520 630 50597967
Acute myeloid leukaemia 24.02 16.69 18 6509 15056 50583541
Myocarditis 23.64 16.69 14 6513 7933 50590664
Memory impairment 23.47 16.69 39 6488 79321 50519276
Febrile neutropenia 22.46 16.69 43 6484 97624 50500973
Oesophageal mass 21.28 16.69 4 6523 52 50598545
Thinking abnormal 21.25 16.69 14 6513 9553 50589044
Tenderness 20.72 16.69 18 6509 18547 50580050
Gambling 20.54 16.69 5 6522 231 50598366
Paraesthesia 19.59 16.69 46 6481 120197 50478400
Neutropenia 19.29 16.69 52 6475 147913 50450684
Sweat gland tumour 18.66 16.69 4 6523 104 50598493
VIth nerve paralysis 18.54 16.69 6 6521 787 50597810
Lip dry 18.47 16.69 10 6517 4777 50593820
Papilloedema 18.46 16.69 9 6518 3464 50595133
Photophobia 17.77 16.69 15 6512 14872 50583725
Erythema 17.64 16.69 50 6477 146364 50452233
Hypercalcaemia 17.21 16.69 18 6509 23334 50575263
Chloasma 16.87 16.69 3 6524 28 50598569
Application site dryness 16.85 16.69 4 6523 166 50598431

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Differentiation syndrome 751.97 26.39 121 2307 992 29571107
Idiopathic intracranial hypertension 195.41 26.39 35 2393 560 29571539
Product use in unapproved indication 84.24 26.39 64 2364 86811 29485288
Haematopoietic neoplasm 82.44 26.39 12 2416 44 29572055
Acute myeloid leukaemia 80.38 26.39 35 2393 16478 29555621
Hyperleukocytosis 80.29 26.39 20 2408 1615 29570484
Leukaemia recurrent 72.19 26.39 18 2410 1459 29570640
Electrocardiogram QT prolonged 69.94 26.39 41 2387 36096 29536003
Cytogenetic abnormality 55.54 26.39 13 2415 806 29571293
Scrotal ulcer 48.26 26.39 10 2418 351 29571748
Hypokalaemia 44.19 26.39 35 2393 50168 29521931
Febrile neutropenia 39.09 26.39 47 2381 112193 29459906
Myelodysplastic syndrome 36.52 26.39 21 2407 17773 29554326
IIIrd nerve paralysis 35.02 26.39 8 2420 445 29571654
Neutropenia 34.64 26.39 48 2380 131663 29440436
Hypomagnesaemia 31.59 26.39 19 2409 17449 29554650
Lymphopenia 30.54 26.39 17 2411 13516 29558583
Large granular lymphocytosis 29.49 26.39 6 2422 192 29571907
Activated partial thromboplastin time prolonged 26.90 26.39 13 2415 7729 29564370

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Differentiation syndrome 1284.49 17.59 221 7534 1833 64489144
Idiopathic intracranial hypertension 240.41 17.59 57 7698 2536 64488441
Myelodysplastic syndrome transformation 160.18 17.59 32 7723 627 64490350
Product use in unapproved indication 129.38 17.59 131 7624 176487 64314490
Leukaemia recurrent 107.36 17.59 30 7725 2564 64488413
Blepharospasm 99.56 17.59 30 7725 3345 64487632
Hyperleukocytosis 90.89 17.59 25 7730 2015 64488962
Acute myeloid leukaemia 81.24 17.59 47 7708 27416 64463561
Haematopoietic neoplasm 71.63 17.59 12 7743 82 64490895
Intracranial pressure increased 67.57 17.59 27 7728 6962 64484015
Cytogenetic abnormality 66.43 17.59 17 7738 1037 64489940
Taste disorder 66.19 17.59 29 7726 9404 64481573
Myelodysplastic syndrome 58.07 17.59 38 7717 27541 64463436
Electrocardiogram QT prolonged 49.22 17.59 54 7701 79394 64411583
Second primary malignancy 47.13 17.59 25 7730 12312 64478665
Febrile neutropenia 46.61 17.59 82 7673 187575 64303402
Hypercalcaemia 42.36 17.59 33 7722 31383 64459594
Myocarditis 37.14 17.59 24 7731 17019 64473958
Neutropenia 35.98 17.59 85 7670 239539 64251438
Disseminated intravascular coagulation 35.22 17.59 30 7725 32318 64458659
Migraine 34.37 17.59 40 7715 62637 64428340
Dysphoria 32.44 17.59 14 7741 4374 64486603
Epilepsy 32.29 17.59 29 7726 33502 64457475
Polyarteritis nodosa 31.63 17.59 8 7747 465 64490512
Gastrointestinal toxicity 29.85 17.59 14 7741 5308 64485669
Hypoaesthesia 28.50 17.59 56 7699 139052 64351925
Chloroma 28.47 17.59 8 7747 697 64490280
Lower respiratory tract infection fungal 26.94 17.59 8 7747 847 64490130
Haemorrhagic diathesis 26.36 17.59 13 7742 5501 64485476
Chromosomal deletion 25.53 17.59 5 7750 88 64490889
IIIrd nerve paralysis 25.14 17.59 8 7747 1066 64489911
White blood cell count increased 24.92 17.59 35 7720 65979 64424998
Scrotal ulcer 24.55 17.59 6 7749 303 64490674
Appetite disorder 24.41 17.59 13 7742 6448 64484529
Large granular lymphocytosis 23.82 17.59 6 7749 343 64490634
Papilloedema 23.44 17.59 12 7743 5493 64485484
Acute promyelocytic leukaemia 23.13 17.59 8 7747 1380 64489597
Skin warm 23.01 17.59 12 7743 5705 64485272
Dry skin 22.15 17.59 29 7726 51132 64439845
Ciliary body melanoma 22 17.59 3 7752 3 64490974
Bone marrow necrosis 21.69 17.59 5 7750 196 64490781
Gastrooesophageal reflux disease 21.46 17.59 37 7718 83106 64407871
Tenderness 20.97 17.59 18 7737 19584 64471393
Acute myeloid leukaemia recurrent 20.96 17.59 9 7746 2775 64488202
Photophobia 20.81 17.59 17 7738 17276 64473701
Arthritis infective 20.69 17.59 12 7743 7018 64483959
Oesophageal mass 20.61 17.59 4 7751 67 64490910
Thinking abnormal 19.74 17.59 14 7741 11542 64479435
Acute febrile neutrophilic dermatosis 19.42 17.59 9 7746 3320 64487657
Memory impairment 19.39 17.59 36 7719 85646 64405331
Hypomagnesaemia 19.07 17.59 23 7732 37353 64453624
Paraesthesia 18.31 17.59 46 7709 134476 64356501
Pulmonary tuberculosis 17.77 17.59 11 7744 7233 64483744
Gelatinous transformation of the bone marrow 17.60 17.59 3 7752 23 64490954

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D10AD01 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Retinoids for topical use in acne
ATC D10AD51 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Retinoids for topical use in acne
ATC L01XF01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Retinoids for cancer treatment
FDA CS M0018962 Retinoids
CHEBI has role CHEBI:22586 antioxidants
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:50176 keratolytic drugs
CHEBI has role CHEBI:62488 signal molecules
CHEBI has role CHEBI:63794 retinoid X receptor agonists
CHEBI has role CHEBI:67079 anti-inflammatory agents
CHEBI has role CHEBI:67198 retinoic acid receptor agonists
CHEBI has role CHEBI:67199 activator protein-1 antagonists
CHEBI has role CHEBI:77746 Homo sapiens metabolite
FDA EPC N0000175607 Retinoid
MeSH PA D000970 Antineoplastic Agents
MeSH PA D003879 Dermatologic Agents
MeSH PA D007641 Keratolytic Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chloasma indication 36209000
Acne vulgaris indication 88616000
Acute promyelocytic leukemia, FAB M3 indication 110004001
Hyperkeratosis indication 396228006
Facial Fine Wrinkling indication
Solar Lentigines indication
Fine Wrinkling indication
Severe Recalcitrant Nodular Acne indication
Kaposi's Sarcoma Skin Lesions indication
Mottle Hyperpigmentation indication
Keratosis follicularis off-label use 48611009 DOID:2734
Lamellar ichthyosis off-label use 205550003
Plane wart off-label use 240539000
Primary cutaneous T-cell lymphoma off-label use 400122007
Severe Recalcitrant Nodular Rosacea off-label use
Osteomalacia contraindication 4598005 DOID:10573
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Rectal hemorrhage contraindication 12063002
Hypercholesterolemia contraindication 13644009
Hearing loss contraindication 15188001
Agranulocytosis contraindication 17182001 DOID:12987
Myocardial infarction contraindication 22298006 DOID:5844
Sunburn contraindication 23346002
Atopic dermatitis contraindication 24079001 DOID:3310
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Crohn's disease contraindication 34000006
Depressive disorder contraindication 35489007
Eczema contraindication 43116000
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Vitiligo contraindication 56727007 DOID:12306
Anorexia nervosa contraindication 56882008 DOID:8689
Tinnitus contraindication 60862001
Corneal opacity contraindication 64634000
Ulcerative colitis contraindication 64766004 DOID:8577
Osteoporosis contraindication 64859006 DOID:11476
Benign intracranial hypertension contraindication 68267002 DOID:11459
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Disorder of bone contraindication 76069003 DOID:0080001
Congenital neutropenia contraindication 89655007
Kidney disease contraindication 90708001 DOID:557
Venous thrombosis contraindication 111293003
Leukocytosis contraindication 111583006
Mycosis fungoides contraindication 118618005
Inflammatory disease of liver contraindication 128241005
Bleeding contraindication 131148009
Liver function tests abnormal contraindication 166603001
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Telangiectasia disorder contraindication 247479008
Dyspnea contraindication 267036007
Edema contraindication 267038008
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Keratoconjunctivitis sicca contraindication 302896008 DOID:12895
Neutropenic disorder contraindication 303011007 DOID:1227
Pericardial effusion contraindication 373945007 DOID:118
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Fever contraindication 386661006
Pseudomembranous enterocolitis contraindication 397683000
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Severe diarrhea contraindication 409587002
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Denuded skin contraindication 418242004
Retinoic acid syndrome contraindication 450887006
Pulmonary Infiltrates contraindication
Pleural Effusions contraindication
Predisposition To Hypertriglyceridemia contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.17 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
3%;0.1% TWYNEO GALDERMA LABS LP N214902 July 26, 2021 RX CREAM TOPICAL 9868103 Aug. 8, 2028 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
3%;0.1% TWYNEO GALDERMA LABS LP N214902 July 26, 2021 RX CREAM TOPICAL 10653899 Dec. 30, 2030 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
3%;0.1% TWYNEO GALDERMA LABS LP N214902 July 26, 2021 RX CREAM TOPICAL 10420743 July 12, 2038 TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
0.05% ALTRENO DOW PHARM N209353 Aug. 23, 2018 RX LOTION TOPICAL 10653656 Aug. 22, 2038 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER
0.05% ALTRENO DOW PHARM N209353 Aug. 23, 2018 RX LOTION TOPICAL 11324710 Aug. 22, 2038 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.2%;0.025% CLINDAMYCIN PHOSPHATE AND TRETINOIN SOLARIS PHARMA CORP A212845 Feb. 10, 2022 RX GEL TOPICAL Oct. 9, 2022 COMPETITIVE GENERIC THERAPY
3%;0.1% TWYNEO GALDERMA LABS LP N214902 July 26, 2021 RX CREAM TOPICAL July 26, 2024 NEW COMBINATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Retinoic acid receptor beta Nuclear hormone receptor AGONIST EC50 6.70 WOMBAT-PK CHEMBL
Retinoic acid receptor gamma Nuclear hormone receptor AGONIST EC50 6.70 WOMBAT-PK CHEMBL
Retinoic acid receptor alpha Nuclear hormone receptor AGONIST EC50 6.70 WOMBAT-PK CHEMBL
Nuclear receptor ROR-alpha Nuclear hormone receptor IC50 6.70 CHEMBL
Retinoic acid receptor RXR-alpha Nuclear hormone receptor Ki 9.40 CHEMBL
Retinoic acid receptor RXR-beta Nuclear hormone receptor Ki 9.30 CHEMBL
Retinoic acid receptor RXR-gamma Nuclear hormone receptor Ki 8.85 CHEMBL
Peroxisome proliferator-activated receptor delta Nuclear hormone receptor AGONIST Kd 7.80 IUPHAR
Nuclear receptor ROR-beta Nuclear hormone receptor ANTAGONIST IC50 9.82 IUPHAR
Nuclear receptor ROR-gamma Nuclear hormone receptor IC50 6.70 CHEMBL
Mitogen-activated protein kinase 1 Kinase IC50 6.24 DRUG MATRIX
Nuclear receptor subfamily 2 group E member 1 Nuclear hormone receptor AGONIST EC50 5.74 IUPHAR
Amyloid beta A4 protein Unclassified IC50 6.75 CHEMBL
Nuclear receptor subfamily 2 group C member 2 Nuclear other AGONIST EC50 4.62 IUPHAR
Peptidyl-prolyl cis-trans isomerase NIMA-interacting 1 Unclassified IC50 6.09 CHEMBL
5-hydroxytryptamine receptor 2B GPCR Ki 6.64 DRUG MATRIX
Alpha-synuclein Transporter IC50 5.52 CHEMBL
Adenosine receptor A3 GPCR Ki 5.53 DRUG MATRIX
11-cis retinol dehydrogenase Enzyme Ki 7 WOMBAT-PK
Cellular retinoic acid-binding protein 1 Cytosolic other IC50 6.43 CHEMBL
Retinoic acid receptor RXR-beta Transcription factor Kd 6.51 CHEMBL
Retinoic acid receptor RXR-gamma Transcription factor Kd 6.46 CHEMBL
Cellular retinoic acid-binding protein 1 Cytosolic other Kd 9.40 CHEMBL
Cellular retinoic acid-binding protein 2 Cytosolic other Kd 8.70 CHEMBL
Retinoic acid receptor alpha Transcription factor Kd 7.82 CHEMBL
Retinoic acid receptor RXR-alpha Transcription factor Kd 6 CHEMBL
Retinoic acid receptor beta Transcription factor Kd 7.89 CHEMBL
Retinoic acid receptor gamma Transcription factor Kd 7.74 CHEMBL
Indoleamine 2,3-dioxygenase 2 Enzyme IC50 4.54 CHEMBL

External reference:

IDSource
4018550 VUID
N0000146871 NUI
D00094 KEGG_DRUG
4018550 VANDF
C0040845 UMLSCUI
CHEBI:15367 CHEBI
3KV PDB_CHEM_ID
CHEMBL38 ChEMBL_ID
DB00755 DRUGBANK_ID
D014212 MESH_DESCRIPTOR_UI
444795 PUBCHEM_CID
2644 IUPHAR_LIGAND_ID
2875 INN_ID
5688UTC01R UNII
10753 RXNORM
46802 MMSL
5610 MMSL
d03863 MMSL
001954 NDDF
387305002 SNOMEDCT_US
54972005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Altreno HUMAN PRESCRIPTION DRUG LABEL 1 0187-0005 LOTION 0.50 mg TOPICAL NDA 24 sections
Retin-A MICRO HUMAN PRESCRIPTION DRUG LABEL 1 0187-5140 GEL 1 mg TOPICAL NDA 26 sections
Retin-A MICRO HUMAN PRESCRIPTION DRUG LABEL 1 0187-5140 GEL 1 mg TOPICAL NDA 26 sections
Retin-A MICRO HUMAN PRESCRIPTION DRUG LABEL 1 0187-5144 GEL 0.40 mg TOPICAL NDA 26 sections
Retin-A MICRO HUMAN PRESCRIPTION DRUG LABEL 1 0187-5144 GEL 0.40 mg TOPICAL NDA 26 sections
Retin-A MICRO HUMAN PRESCRIPTION DRUG LABEL 1 0187-5146 GEL 0.60 mg TOPICAL NDA 26 sections
Retin-A MICRO HUMAN PRESCRIPTION DRUG LABEL 1 0187-5146 GEL 0.60 mg TOPICAL NDA 26 sections
Retin-A MICRO HUMAN PRESCRIPTION DRUG LABEL 1 0187-5148 GEL 0.80 mg TOPICAL NDA 26 sections
Retin-A MICRO HUMAN PRESCRIPTION DRUG LABEL 1 0187-5148 GEL 0.80 mg TOPICAL NDA 26 sections
Renova HUMAN PRESCRIPTION DRUG LABEL 1 0187-5150 CREAM 0.20 mg TOPICAL NDA 25 sections
Retin-A HUMAN PRESCRIPTION DRUG LABEL 1 0187-5160 CREAM 0.25 mg TOPICAL NDA 21 sections
Retin-A HUMAN PRESCRIPTION DRUG LABEL 1 0187-5162 CREAM 0.50 mg TOPICAL NDA 21 sections
Retin-A HUMAN PRESCRIPTION DRUG LABEL 1 0187-5164 CREAM 1 mg TOPICAL NDA 21 sections
Retin-A HUMAN PRESCRIPTION DRUG LABEL 1 0187-5170 GEL 0.25 mg TOPICAL NDA 21 sections
Retin-A HUMAN PRESCRIPTION DRUG LABEL 1 0187-5172 GEL 0.10 mg TOPICAL NDA 21 sections
TWYNEO HUMAN PRESCRIPTION DRUG LABEL 2 0299-5945 CREAM 1 mg TOPICAL NDA 26 sections
TRI-LUMA HUMAN PRESCRIPTION DRUG LABEL 3 0299-5950 CREAM 0.50 mg TOPICAL NDA 24 sections
TRI-LUMA HUMAN PRESCRIPTION DRUG LABEL 3 0299-5950 CREAM 0.50 mg TOPICAL NDA 24 sections
Avita HUMAN PRESCRIPTION DRUG LABEL 1 0378-6140 GEL 0.25 mg TOPICAL NDA 22 sections
Avita HUMAN PRESCRIPTION DRUG LABEL 1 0378-6141 CREAM 0.25 mg TOPICAL NDA 21 sections
Tretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0378-8082 CREAM 0.25 mg TOPICAL NDA authorized generic 20 sections
Tretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0378-8083 CREAM 0.50 mg TOPICAL NDA authorized generic 20 sections
Tretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0378-8084 CREAM 1 mg TOPICAL NDA authorized generic 20 sections
Tretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0378-8085 GEL 0.10 mg TOPICAL NDA authorized generic 20 sections
Tretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0378-8086 GEL 0.25 mg TOPICAL NDA authorized generic 20 sections
Tretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0378-8090 GEL 0.50 mg TOPICAL ANDA 24 sections
Tretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0378-8092 GEL 0.40 mg TOPICAL NDA authorized generic 25 sections
Tretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0378-8093 GEL 1 mg TOPICAL NDA authorized generic 25 sections
Tretinoin HUMAN PRESCRIPTION DRUG LABEL 1 0472-0117 CREAM 0.25 mg TOPICAL NDA AUTHORIZED GENERIC 22 sections
Clindamycin Phosphate and Tretinoin HUMAN PRESCRIPTION DRUG LABEL 2 0472-1790 GEL 0.25 mg TOPICAL ANDA 16 sections