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Setid 97c531eb D922 445b 894b 74d644d4f0aa Applno 19155 Form Lotion Topical Dosage Eq 12 Base - Drug Product Composition: Ammonium Lactate

Ammonium Lactate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

7 API Suppliers, 5 USDMF, 4 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

9 FDF Dossiers, 8 FDA Orange Book, 1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 2 DKSH, 2 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 4 Actylis, 1 Aeon Procare, 6 BASF, 1 CD Formulation, 2 Corel Pharma Chem, 1 Finar, 4 Gangwal Chemicals, 2 Lubrizol Life Science Health, 3 Microlex e.U, 1 Nanjing Bold Chemical, 1 Pluviaendo, 4 Roquette, 7 Seppic, 1 Sigachi Industries, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

19 Topical, 15 Solubilizers, 11 Parenteral, 10 Film Formers & Plasticizers, 10 Thickeners and Stabilizers, 6 Emulsifying Agents, 6 Coating Systems & Additives, 4 Fillers, Diluents & Binders, 4 Surfactant & Foaming Agents, 4 Lubricants & Glidants, 2 Co-Processed Excipients, 2 API Stability Enhancers, 2 Direct Compression, 1 Disintegrants & Superdisintegrants, 1 Granulation, 1 Taste Masking, 1 Rheology Modifiers, 1 Controlled & Modified Release, 1 Chewable & Orodispersible Aids

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 4 Regulatory FDF Prices

MARKET PLACE

2 APIs

2 APIs

$ Xls

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USFDA APPLICATION NUMBER - 19155 / DOSAGE - LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMMONIUM LACTATE(UNII: 67M901L9NQ) (LACTIC ACID - UNII:33X04XA5AT)	AMMONIUM LACTATE	120mg in 1

Inactive Ingredients

Ingredient Name	Ranbaxy Laboratories Inc.
CETYL ALCOHOL(936JST6JCN)
GLYCERIN(PDC6A3C0OX)
LAURETH-4(6HQ855798J)
LIGHT MINERAL OIL(N6K5787QVP)
MAGNESIUM ALUMINUM SILICATE(6M3P64V0NC)
METHYLCELLULOSE (100 CPS)(4GFU244C4J)
METHYLPARABEN(A2I8C7HI9T)
POLYOXYL 40 STEARATE(13A4J4NH9I)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
WATER(059QF0KO0R)

Setid 97c531eb D922 445b 894b 74d644d4f0aa Applno 19155 Form Lotion Topical Dosage Eq 12 Base - Drug Product Composition: Ammonium Lactate

Ammonium Lactate

Ammonium Lactate

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

7 API Suppliers

5 USDMF

4 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

9 FDF Dossiers

8 FDA Orange Book

1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

2 DKSH

2 Nanjing Well Pharmaceutical

2 Kirsch Pharma

4 Actylis

1 Aeon Procare

6 BASF

1 CD Formulation

2 Corel Pharma Chem

1 Finar

4 Gangwal Chemicals

2 Lubrizol Life Science Health

3 Microlex e.U

1 Nanjing Bold Chemical

1 Pluviaendo

4 Roquette

7 Seppic

1 Sigachi Industries

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

19 Topical

15 Solubilizers

11 Parenteral

10 Film Formers & Plasticizers

10 Thickeners and Stabilizers

6 Emulsifying Agents

6 Coating Systems & Additives

4 Fillers, Diluents & Binders

4 Surfactant & Foaming Agents

4 Lubricants & Glidants

2 Co-Processed Excipients

2 API Stability Enhancers

2 Direct Compression

1 Disintegrants & Superdisintegrants

1 Granulation

1 Taste Masking

1 Rheology Modifiers

1 Controlled & Modified Release

1 Chewable & Orodispersible Aids

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

4 Regulatory FDF Prices

MARKET PLACE

2 APIs

Filters

LOTION;TOPICAL - EQ 12% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CREAM;TOPICAL - EQ 12% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons