Amphetamine Aspartate Monohydrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 10 USDMF, 11 NDC API, 4 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

267 FDF Dossiers, 267 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

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

1 Evonik, 2 Rochem International Inc, 5 SPI Pharma, 8 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 BASF, 11 Corel Pharma Chem, 2 DFE Pharma, 7 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 22 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

54 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 28 Controlled & Modified Release, 27 Direct Compression, 23 Thickeners and Stabilizers, 16 Lubricants & Glidants, 15 Granulation, 14 Taste Masking, 12 Disintegrants & Superdisintegrants, 12 Film Formers & Plasticizers, 12 Co-Processed Excipients, 11 Solubilizers, 9 Empty Capsules, 7 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 4 Emulsifying Agents, 3 Parenteral, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Topical

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 Annual Reports

5 Annual Reports

MARKET PLACE

1 APIs

1 APIs

PATENTS & EXCLUSIVITIES

8 US Patents

8 US Patents

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21303 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMPHETAMINE ASPARTATE MONOHYDRATE(UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E)	AMPHETAMINE ASPARTATE MONOHYDRATE	1.25mg \| 2.5mg \| 3.75mg \| 5mg \| 6.25mg \| 7.5mg
AMPHETAMINE SULFATE(UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)	AMPHETAMINE SULFATE	1.25mg \| 2.5mg \| 3.75mg \| 5mg \| 6.25mg \| 7.5mg
DEXTROAMPHETAMINE SACCHARATE(UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)	DEXTROAMPHETAMINE SACCHARATE	1.25mg \| 2.5mg \| 3.75mg \| 5mg \| 6.25mg \| 7.5mg
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)	DEXTROAMPHETAMINE SULFATE	1.25mg \| 2.5mg \| 3.75mg \| 5mg \| 6.25mg \| 7.5mg

Inactive Ingredients

Ingredient Name	Par Pharmaceutical, Inc.	American Health Packaging	Amneal Pharmaceuticals of New York LLC	Ascent Pharmaceuticals, Inc	Bryant Ranch Prepack	Actavis Pharma, Inc.	Zydus Pharmaceuticals (USA) Inc.	Amerigen Pharmaceuticals Inc.	Barr Laboratories Inc.	Sun Pharmaceutical Industries, Inc.
ALCOHOL(3K9958V90M)
AMMONIA(5138Q19F1X)
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)
BUTYL ALCOHOL(8PJ61P6TS3)
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES(U72Q2I8C85)
D&C RED NO. 28(767IP0Y5NH)
D&C RED NO. 33(9DBA0SBB0L)
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)
D&C YELLOW NO. 10(35SW5USQ3G)
DEHYDRATED ALCOHOL(3K9958V90M)
FD&C BLUE NO. 1 ALUMINUM LAKE(J9EQA3S2JM)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)
FD&C RED NO. 3(PN2ZH5LOQY)
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)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)(XRK36F13ZZ)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POTASSIUM HYDROXIDE(WZH3C48M4T)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
Tert-butyl alcohol(MD83SFE959)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)
WATER(059QF0KO0R)

Drug Product Composition: Amphetamine Aspartate Monohydrate