(+-)-Amphetamine sulfate | 21303 | CAPSULE, EXTENDED RELEASE;ORAL | 3.75MG;3.75MG;3.75MG;3.75MG

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

474 FDF Dossiers, 429 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, 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, 7 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, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

93 Fillers, Diluents & Binders, 68 Coating Systems & Additives, 49 Controlled & Modified Release, 47 Direct Compression, 37 Thickeners and Stabilizers, 35 Taste Masking, 33 Solubilizers, 31 Disintegrants & Superdisintegrants, 30 Granulation, 23 Film Formers & Plasticizers, 22 Parenteral, 19 Chewable & Orodispersible Aids, 19 Lubricants & Glidants, 19 Co-Processed Excipients, 18 Topical, 9 Emulsifying Agents, 9 Empty Capsules, 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, 106 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 - 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 sulfate