Betamethasone Dipropionate

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35 Drugs in Development

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DRUG PRODUCT COMPOSITIONS

OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE, CREAM;TOPICAL - EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - EQ 0.05% BASE, OINTMENT;TOPICAL - EQ 0.05% BASE, CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, OINTMENT;TOPICAL - 0.064%;0.005%, SUSPENSION;TOPICAL - 0.064%;0.005%

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1 Rochem International Inc, 2 SPI Pharma, 3 DKSH, 1 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 3 Kirsch Pharma, 1 Actylis, 11 BASF, 1 Clariant, 4 Corel Pharma Chem, 2 Finar, 4 Lubrizol Life Science Health, 11 Roquette, 1 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Valens Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 18827 / DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
BETAMETHASONE DIPROPIONATE(UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)	BETAMETHASONE	0.5mg in 1
CLOTRIMAZOLE(UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10mg in 1

Inactive Ingredients

Ingredient Name	Merck Sharp & Dohme Corp.	Prasco Laboratories
benzyl alcohol(LKG8494WBH)
CETEARETH-30(1R9DCZ5FOX)
cetyl alcohol(936JST6JCN)
mineral oil(T5L8T28FGP)
petrolatum(4T6H12BN9U)
phosphoric acid(E4GA8884NN)
propylene glycol(6DC9Q167V3)
SODIUM HYDROXIDE(55X04QC32I)
sodium phosphate, monobasic, monohydrate(593YOG76RN)
STEARYL ALCOHOL(2KR89I4H1Y)
water(059QF0KO0R)

Setid F4e9d5a1 Cc99 4907 Bc62 A636fc0dcab5 Applno 18827 Form Cream Topical Dosage Eq 0 05 Base 1 - Drug Product Composition: Betamethasone Dipropionate