Triamcinolone Acetonide

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CREAM;TOPICAL - 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML, SPRAY;TOPICAL - 0.147MG/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 40MG/ML, INJECTABLE;INJECTION - 80MG/ML, SPRAY, METERED;NASAL - 0.055MG/SPRAY, FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR - 32MG/VIAL, CREAM;TOPICAL - 0.025%, CREAM;TOPICAL - 0.1%, CREAM;TOPICAL - 0.5%, OINTMENT;TOPICAL - 0.025%, OINTMENT;TOPICAL - 0.1%, OINTMENT;TOPICAL - 0.5%

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2 EUROAPI, 4 Rochem International Inc, 9 SPI Pharma, 13 DKSH, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 3 Gangwal Healthcare, 13 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 15 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 22 BASF, 1 Clariant, 2 DFE Pharma, 6 Finar, 12 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 8 Kerry, 1 Kima Chemical, 3 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 19 Roquette, 12 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 1 The Dow Chemical Company, 1 Valens Pharmachem, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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USFDA APPLICATION NUMBER - 14901 / DOSAGE - INJECTABLE;INJECTION - 40MG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRIAMCINOLONE ACETONIDE(UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)	TRIAMCINOLONE ACETONIDE	40mg

Inactive Ingredients

Ingredient Name	Proficient Rx LP	RX PHARMA-PACK, INC.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	Sandoz Inc	Terrain Pharmaceuticals
ALCOHOL(3K9958V90M)
BENZYL ALCOHOL(LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
ENGLISH LAVENDER OIL(ZBP1YXW0H8)
FD&C RED NO. 40(WZB9127XOA)
HYDROCHLORIC ACID(QTT17582CB)
LAVENDER OIL(ZBP1YXW0H8)
LEMON OIL(I9GRO824LL)
LEMON(24RS0A988O)
METHYLPARABEN(A2I8C7HI9T)
NITROGEN(N762921K75)
NONOXYNOL-9(48Q180SH9T)
NUTMEG OIL(Z1CLM48948)
polysorbate 80(6OZP39ZG8H)
sodium chloride(451W47IQ8X)
sodium hydroxide(55X04QC32I)
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)
WATER(059QF0KO0R)

Drug Product Composition: Triamcinolone Acetonide