(+-)-Amphetamine sulfate | 17078 | CAPSULE, EXTENDED RELEASE;ORAL | 10MG

Amphetamine Sulfate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 25 USDMF, 3 CEP/COS, 15 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

468 FDF Dossiers, 423 FDA Orange Book, 19 Europe, 6 Canada, 1 Australia, 3 South Africa, 16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 5MG, SUSPENSION, EXTENDED RELEASE;ORAL - EQ 1.25MG BASE/ML, TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 12.5MG BASE, TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 15.7MG BASE, TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 18.8MG BASE, TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 3.1MG BASE, TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 6.3MG BASE, TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 9.4MG BASE, SUSPENSION, EXTENDED RELEASE;ORAL - 2MG/ML;EQ 0.5MG BASE/ML, TABLET, EXTENDED RELEASE;ORAL - 12MG;EQ 3MG BASE, TABLET, EXTENDED RELEASE;ORAL - 16MG;EQ 4MG BASE, TABLET, EXTENDED RELEASE;ORAL - 4MG;EQ 1MG BASE, TABLET, EXTENDED RELEASE;ORAL - 8MG;EQ 2MG BASE, CAPSULE, EXTENDED RELEASE;ORAL - 1.25MG;1.25MG;1.25MG;1.25MG, CAPSULE, EXTENDED RELEASE;ORAL - 2.5MG;2.5MG;2.5MG;2.5MG, CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG, CAPSULE, EXTENDED RELEASE;ORAL - 5MG;5MG;5MG;5MG, CAPSULE, EXTENDED RELEASE;ORAL - 6.25MG;6.25MG;6.25MG;6.25MG, CAPSULE, EXTENDED RELEASE;ORAL - 7.5MG;7.5MG;7.5MG;7.5MG

RELATED EXCIPIENT COMPANIES

4 Evonik, 7 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 11 DKSH, 1 Jai Radhe Sales, 2 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 35 BASF, 1 Bioplus Life Sciences, 21 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 12 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 33 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

94 Fillers, Diluents & Binders, 68 Coating Systems & Additives, 49 Controlled & Modified Release, 48 Direct Compression, 37 Thickeners and Stabilizers, 35 Taste Masking, 34 Solubilizers, 32 Disintegrants & Superdisintegrants, 30 Granulation, 23 Film Formers & Plasticizers, 22 Parenteral, 19 Co-Processed Excipients, 19 Chewable & Orodispersible Aids, 19 Lubricants & Glidants, 18 Topical, 9 Empty Capsules, 9 Emulsifying Agents, 8 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 104 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 30 Finished Drug Prices, 18 Annual Reports

MARKET PLACE

11 APIs, 1 Intermediates

PATENTS & EXCLUSIVITIES

107 US Patents, 4 US Exclusivities

REF. STANDARDS & IMPURITIES

5 USP, 8 Others

$ Xls

Filters

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USFDA APPLICATION NUMBER - 17078 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)	DEXTROAMPHETAMINE SULFATE	15mg \| 5mg \| 10mg

Inactive Ingredients

Ingredient Name	American Health Packaging	Vensun Pharmaceuticals, LLC.	Mylan Pharmaceuticals Inc.	Amedra Pharmaceuticals LLC	Amneal Pharmaceuticals of New York LLC	Lineage Therapeutics Inc	Par Pharmaceutical	Avera McKennan Hospital	Teva Pharmaceuticals, USA, Inc.	Zydus Pharmaceuticals (USA) Inc.
Alcohol(3K9958V90M)
ALUMINUM OXIDE(LMI26O6933)
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
CETYL ALCOHOL(936JST6JCN)
D&C RED NO. 28(767IP0Y5NH)
D&C RED NO. 33(9DBA0SBB0L)
D&C RED NO. 7(ECW0LZ41X8)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBUTYL SEBACATE(4W5IH7FLNY)
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)
ETHYLCELLULOSE (20 MPA.S)(BJG0S321QY)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
ISOPROPYL ALCOHOL(ND2M416302)
MAGNESIUM STEARATE(70097M6I30)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
METHYLCELLULOSE (15 MPA.S)(NPU9M2E6L8)
OLEIC ACID(2UMI9U37CP)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
silicon dioxide(ETJ7Z6XBU4)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)

Drug Product Composition: (+-)-Amphetamine sulfate