List of Drug Master Files (DMF) of Calcipotriene Active Pharmaceutical Ingredient listed on PharmaCompass.com

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 21 USDMF, 11 CEP/COS, 1 EU WC, 1 KDMF, 14 NDC API, 20 Listed Suppliers, $ API Reference Price

39 API Suppliers
21 USDMF
11 CEP/COS
1 EU WC
1 KDMF
14 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

113 FDF Dossiers, 23 FDA Orange Book, 55 Europe, 23 Canada, 7 South Africa, 5 Listed Dossiers

113 FDF Dossiers
23 FDA Orange Book
55 Europe
23 Canada
7 South Africa
5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 0.005%, SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, OINTMENT;TOPICAL - 0.064%;0.005%, SUSPENSION;TOPICAL - 0.064%;0.005%, AEROSOL, FOAM;TOPICAL - 0.005%

drugProductComposition
CREAM;TOPICAL - 0.005%
SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
OINTMENT;TOPICAL - 0.064%;0.005%
SUSPENSION;TOPICAL - 0.064%;0.005%
AEROSOL, FOAM;TOPICAL - 0.005%

RELATED EXCIPIENT COMPANIES

1 DKSH, 5 Nanjing Well Pharmaceutical, 3 Actylis, 1 Alcedo Pharmachem, 12 BASF, 1 Corel Pharma Chem, 2 Finar, 1 Kerry, 1 Pluviaendo, 1 Seppic, 1 Valens Pharmachem

relatedExcipients
1 DKSH
5 Nanjing Well Pharmaceutical
3 Actylis
1 Alcedo Pharmachem
12 BASF
1 Corel Pharma Chem
2 Finar
1 Kerry
1 Pluviaendo
1 Seppic
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

18 Topical, 7 Solubilizers, 6 Parenteral, 5 Emulsifying Agents, 4 Film Formers & Plasticizers, 4 Lubricants & Glidants, 4 Thickeners and Stabilizers, 3 Controlled & Modified Release, 2 Granulation, 2 Direct Compression, 1 Surfactant & Foaming Agents, 1 Coating Systems & Additives

excipientsByApplications
18 Topical
7 Solubilizers
6 Parenteral
5 Emulsifying Agents
4 Film Formers & Plasticizers
4 Lubricants & Glidants
4 Thickeners and Stabilizers
3 Controlled & Modified Release
2 Granulation
2 Direct Compression
1 Surfactant & Foaming Agents
1 Coating Systems & Additives

DIGITAL CONTENT

27 NEWS #PharmaBuzz

media
27 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 54 Finished Drug Prices, 7 Annual Reports

globalSalesInformation
3 US Medicaid Prescriptions
54 Finished Drug Prices
7 Annual Reports

MARKET PLACE

9 APIs, 1 FDF Dossiers

marketPlace
9 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 1 Health Canada Patents

patents
18 US Patents
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 2 USP , 1 Others

otherSolutions
3 EDQM
2 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 1,074,476

MARKET PLACE

API

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

113

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

14DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

30,042,632

Annual Reports (USD Million)

405

Finished Drug Prices

29 RELATED EXCIPIENT COMPANIES

57EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Calcipotriene, Dovonex, Daivonex, Sorilux, 112965-21-6, Calciptriol

Molecular Formula

C₂₇H₄₀O₃

Molecular Weight

412.6 g/mol

InChI Key

LWQQLNNNIPYSNX-UROSTWAQSA-N

FDA UNII

143NQ3779B

Calcipotriene is a synthetic vitamin D derivative usually formulated for topical dermatological use, antipsoriatic Calcipotriene (calcipotriol) competes equally with active 1,25-hydroxy-2D3 (the natural form of vitamin D) for 1,25-hydroxy-2D3 receptors in regulating cell proliferation and differentiation. It induces differentiation and suppresses proliferation of keratinocytes, reversing abnormal keratinocyte changes in psoriasis, and leads to normalization of epidermal growth. (NCI04)

Calcipotriene is a Vitamin D Analog.

1 2D Structure

Calcipotriol

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(1R,3S,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R,5S)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol

2.1.2 InChI

InChI=1S/C27H40O3/c1-17(6-13-25(29)20-8-9-20)23-11-12-24-19(5-4-14-27(23,24)3)7-10-21-15-22(28)16-26(30)18(21)2/h6-7,10,13,17,20,22-26,28-30H,2,4-5,8-9,11-12,14-16H2,1,3H3/b13-6+,19-7+,21-10-/t17-,22-,23-,24+,25-,26+,27-/m1/s1

2.1.3 InChI Key

LWQQLNNNIPYSNX-UROSTWAQSA-N

2.1.4 Canonical SMILES

CC(C=CC(C1CC1)O)C2CCC3C2(CCCC3=CC=C4CC(CC(C4=C)O)O)C

2.1.5 Isomeric SMILES

C[C@H](/C=C/[C@H](C1CC1)O)[C@H]2CC[C@@H]\3[C@@]2(CCC/C3=C\C=C/4\C[C@H](C[C@@H](C4=C)O)O)C

2.2 Other Identifiers

2.2.1 UNII

143NQ3779B

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1,24(oh)2-22-ene-24-cyclopropyl D3

2. Calcipotriene

3. Daivonex

4. Dovonex

5. Heximar Win Care

6. Mc 903

7. Mc-903

8. Pri-2205

9. Psorcutan

10. Sorilux

2.3.2 Depositor-Supplied Synonyms

1. Calcipotriene

2. Dovonex

3. Daivonex

4. Sorilux

5. 112965-21-6

6. Calciptriol

7. Psorcutan

8. Calcipotriol Hydrate

9. Mc 903

10. Calcitrene

11. Mc-903

12. Calcipotriene [usan]

13. Calcipotriol [inn]

14. Calcipotriol Anhydrous

15. Chebi:50749

16. Dovonex (tn)

17. 112828-00-9

18. Pri-2201

19. Calcipotriol (jan)

20. 143nq3779b

21. (1r,3s,5z)-5-[(2e)-2-[(1r,3as,7ar)-1-[(e,2r,5s)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol

22. Ncgc00167465-01

23. Calcipotriol [jan]

24. Dsstox_cid_26648

25. Dsstox_rid_81793

26. Dsstox_gsid_46648

27. Divonex

28. (22e)-(24s)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydrovitamin D3 / (22e)-(24s)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydrocholecalciferol / Calcipotriol

29. (5z,7e,22e)-(1s,3r,24s)-26,27-cyclo-9,10-seco-5,7,10(19),22-cholestatetraene-1,3,24-triol

30. Smr000466353

31. Cas-112965-21-6

32. Sr-01000762910

33. Ccris 7700

34. Unii-143nq3779b

35. Pri 2201

36. Calcipotriene (usp)

37. Bms-181161

38. Calcipotrienemc 903

39. Calcipotriene [mi]

40. Epitope Id:114242

41. Schembl2853

42. Calcipotriene [vandf]

43. Calcipotriol [mart.]

44. Mls000759467

45. Mls001424130

46. Calcipotriol [who-dd]

47. Calcipotriene [usp-rs]

48. Gtpl2778

49. Chembl1200666

50. Dtxsid0046648

51. Amy2864

52. 1s19

53. Hms2051n11

54. Hms2089j08

55. Hms3269p03

56. Hms3413d04

57. Hms3677d04

58. Hms3713k08

59. Mc903

60. Calcipotriene [orange Book]

61. Calcipotriol [ep Monograph]

62. Ex-a4430

63. Zinc3921872

64. Tox21_112469

65. Bdbm50369964

66. Calcipotriene [usp Monograph]

67. Lmst03020106

68. S3739

69. Akos015855239

70. Tox21_112469_1

71. Ccg-100949

72. Cs-0387

73. Db02300

74. Nc00199

75. Stf-115469

76. Ncgc00167465-02

77. (5z,7e,22e,24s)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1alpha,3beta,24-triol

78. As-56390

79. Cpd000466353

80. Hy-10001

81. D01125

82. U-0267

83. Ab00698343-05

84. 828c009

85. Q155683

86. Sr-01000762910-3

87. Sr-01000762910-4

88. (1?,3?,5z,7e,22e,24s)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol

89. (1s,3r,5z,7e,14beta,17alpha,22e,24s)-26,27-cyclo-9,10-secocholesta-5,7,10,22-tetraene-1,3,24-triol

90. (5z,7e,22e,24s)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1.alpha.,3.beta.,24-triol

91. (5z,7e,24s)-26,27-cyclo-9,10-secocholesta-5,7,10(19),22-tetraene-1alpha,3beta,24-triol

92. 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1.alpha.,3.beta.,5z,7e,22e,24s)-

93. 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1alpha,3beta,5z,7e,22e,24s)-

2.4 Create Date

2005-11-29

3 Chemical and Physical Properties

Molecular Formula	C₂₇H₄₀O₃
Molecular Weight	412.6 g/mol
XLogP3	4.3
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	5
Exact Mass	412.29774513 g/mol
Monoisotopic Mass	412.29774513 g/mol
Topological Polar Surface Area	60.7 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	743
Isotope Atom Count	0
Defined Atom Stereocenter Count	7
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	3
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Calcipotriene
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	Dovonex (calcipotriene solution) Scalp Solution, 0.005% is a colorless topical solution containing calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatologic use.Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)...
Active Ingredient	Calcipotriene
Dosage Form	Ointment; Cream; Solution
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Glenmark Generics; Fougera Pharms; Tolmar; G And W Labs

2 of 6
Drug Name	Dovonex
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	Dovonex (calcipotriene solution) Scalp Solution, 0.005% is a colorless topical solution containing calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatologic use.Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)...
Active Ingredient	Calcipotriene
Dosage Form	Cream
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Leo Pharma As

3 of 6
Drug Name	Sorilux
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	SORILUX Foam contains the compound calcipotriene, a synthetic vitamin D3 analog.Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1,3,24-triol. The structural formula is represented below:Molecular...
Active Ingredient	Calcipotriene
Dosage Form	Aerosol, foam
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Stiefel Labs

4 of 6
Drug Name	Calcipotriene
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	Dovonex (calcipotriene solution) Scalp Solution, 0.005% is a colorless topical solution containing calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatologic use.Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)...
Active Ingredient	Calcipotriene
Dosage Form	Ointment; Cream; Solution
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Glenmark Generics; Fougera Pharms; Tolmar; G And W Labs

5 of 6
Drug Name	Dovonex
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	Dovonex (calcipotriene solution) Scalp Solution, 0.005% is a colorless topical solution containing calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatologic use.Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)...
Active Ingredient	Calcipotriene
Dosage Form	Cream
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Leo Pharma As

6 of 6
Drug Name	Sorilux
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	SORILUX Foam contains the compound calcipotriene, a synthetic vitamin D3 analog.Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1,3,24-triol. The structural formula is represented below:Molecular...
Active Ingredient	Calcipotriene
Dosage Form	Aerosol, foam
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Stiefel Labs

4.2 Drug Indication

For the treatment of moderate plaque psoriasis in adults.

Treatment of psoriasis

5 Pharmacology and Biochemistry

5.1 Pharmacology

Calcipotriene is a synthetic analog of vitamin D. In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D3 (cholecalciferol) in the skin.

5.2 MeSH Pharmacological Classification

Dermatologic Agents

Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

CALCIPOTRIENE

5.3.2 FDA UNII

143NQ3779B

5.3.3 Pharmacological Classes

Vitamin D [CS]; Vitamin D Analog [EPC]

5.4 ATC Code

D05AX52

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

D - Dermatologicals

D05 - Antipsoriatics

D05A - Antipsoriatics for topical use

D05AX - Other antipsoriatics for topical use

D05AX02 - Calcipotriol

5.5 Absorption, Distribution and Excretion

Absorption

Clinical studies with radiolabeled ointment indicate that approximately 6% (+3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques or 5% (+2.6%, SO) when applied to normal skin.

Route of Elimination

The active form of the vitamin, 1,25-dihydroxy vitamin D3 (calcitriol), is known to be recycled via the liver and excreted in the bile. There is evidence that maternal 1,25-dihydroxy vitamin D3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk.

5.6 Metabolism/Metabolites

Hepatic. Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone. The primary metabolites are much less potent than the parent compound.

5.7 Mechanism of Action

The precise mechanism of calcipotriol in remitting psoriasis is not well-understood, however, it has been shown to have comparable affinity with calcitriol for the Vitamin D receptor while being less than 1% the activity in regulating calcium metabolism. The Vitamin D receptor (VDR) belongs to the steroid/thyroid receptor superfamily, and is found on the cells of many different tissues including the thyroid, bone, kindney, and T cells of the immune system. T cells are known to play a role in psoriasis and are believed to undergo modulation of gene expression with binding of calcipotriol to the VDR. This modulation is thought to affect gene products related to cell differentiation and proliferation.

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MAHARASHTRA","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.61","actualQuantity":"612","unit":"GMS","unitRateFc":"1050","totalValueFC":"656585.4","currency":"USD","unitRateINR":"89092.5","date":"26-Aug-2024","totalValueINR":"54524610","totalValueInUsd":"656585.4","indian_port":"Bombay Air","hs_no":"29362990","bill_no":"5254843","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"36 HOPING STREET, LOUCHU,TAOYUAN 33842,.SDNF TAIWAN","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724610600,"product":"CALCIPOTRIENE(CALCIPOTRIOL)(CALCIPOTRIENE USPCALCIPOTRIOL ANHYDROUS)(LOT NO.F042L1-24001-71.71\/F042L1-23014-19.92\/F042L1","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.15","actualQuantity":"154.3","unit":"GMS","unitRateFc":"1050","totalValueFC":"165541","currency":"USD","unitRateINR":"89092.5","date":"26-Aug-2024","totalValueINR":"13746972.75","totalValueInUsd":"165541","indian_port":"Bombay Air","hs_no":"29362990","bill_no":"5254843","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"36 HOPING STREET, LOUCHU,TAOYUAN 33842,.SDNF TAIWAN","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]

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Total Quantity (KGS)

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Quantity (KGS) & Unit rate (USD/KGS) over time

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Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - CREAM;TOPICAL - 0.005%

USFDA APPLICATION NUMBER - 20554

DOSAGE - SOLUTION;TOPICAL - 0.005% **Federal ...DOSAGE - SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20611

DOSAGE - OINTMENT;TOPICAL - 0.064%;0.005%

USFDA APPLICATION NUMBER - 21852

DOSAGE - SUSPENSION;TOPICAL - 0.064%;0.005%

USFDA APPLICATION NUMBER - 22185

DOSAGE - AEROSOL, FOAM;TOPICAL - 0.005%

USFDA APPLICATION NUMBER - 22563

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CREAM;TOPICAL - 0.005%

SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

OINTMENT;TOPICAL - 0.064%;0.005%

SUSPENSION;TOPICAL - 0.064%;0.005%

AEROSOL, FOAM;TOPICAL - 0.005%

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1 Pluviaendo

1 Seppic

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

18 Topical

7 Solubilizers

6 Parenteral

5 Emulsifying Agents

4 Film Formers & Plasticizers

4 Lubricants & Glidants

4 Thickeners and Stabilizers

3 Controlled & Modified Release

2 Granulation

2 Direct Compression

1 Surfactant & Foaming Agents

1 Coating Systems & Additives

DIGITAL CONTENT

27 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions

54 Finished Drug Prices

7 Annual Reports

MARKET PLACE

9 APIs

1 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents

1 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM

2 USP

1 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 1,074,476

MARKET PLACE

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

14DRUGS IN DEVELOPMENT

SOLUTION;TOPICAL - 0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons