Details for New Drug Application (NDA): 213583

NDA 213583 describes AMPHETAMINE SULFATE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Novast Labs, Prinston Inc, Rhodes Pharms, Sanaluz, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc, and is included in sixteen NDAs. It is available from eleven suppliers. Additional details are available on the AMPHETAMINE SULFATE profile page.

The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

Summary for 213583

Tradename:	AMPHETAMINE SULFATE
Applicant:	Specgx Llc
Ingredient:	amphetamine sulfate
Patents:	0

Pharmacology for NDA: 213583

Physiological Effect

Central Nervous System Stimulation

Suppliers and Packaging for NDA: 213583

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	213583	ANDA	SpecGx LLC	0406-1219	0406-1219-01	100 TABLET in 1 BOTTLE (0406-1219-01)
AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	213583	ANDA	SpecGx LLC	0406-1220	0406-1220-01	100 TABLET in 1 BOTTLE (0406-1220-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 22, 2021	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jan 22, 2021	TE:	AA	RLD:	No

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