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Generated: September 25, 2017

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Details for New Drug Application (NDA): 201013

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NDA 201013 describes HYDROCODONE BITARTRATE AND ACETAMINOPHEN, which is a drug marketed by Mallinckrodt, Par Pharm, Barr, Mikart, Mallinckrodt Inc, Ucb Inc, Amneal Pharms Ny, Aurolife Pharma Llc, Tris Pharma Inc, Vintage Pharms, Sun Pharm Inds Inc, Ranbaxy Labs Ltd, Watson Labs, Ranbaxy, Sun Pharm Inds Ltd, Pharm Assoc, Larken Labs Inc, Abhai Llc, Mutual Pharm, Amneal Pharms, Novel Labs Inc, Vistapharm, Apil, Sandoz, Halsey, Able, Caraco, Nesher Pharms, Actavis Labs Fl Inc, Lannett Holdings Inc, Vintage Pharms Llc, Upsher-smith Labs, Usl Pharma, Rhodes Pharms, Watson Labs Florida, and Ivax Pharms, and is included in one hundred and twelve NDAs. It is available from eighty-two suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND ACETAMINOPHEN profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND ACETAMINOPHEN is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Eighty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for NDA: 201013

Tradename:	1
Applicant:	1
Ingredient:	1
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 201013

Mechanism of Action	Opioid Agonists

Suppliers and Packaging for NDA: 201013

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	201013	ANDA	Aurolife Pharma LLC	13107-019	13107-019-01	100 TABLET in 1 BOTTLE (13107-019-01)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	201013	ANDA	Aurolife Pharma LLC	13107-019	13107-019-05	500 TABLET in 1 BOTTLE (13107-019-05)

Summary for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;5MG
Approval Date:	Apr 11, 2012	TE:	AA	RLD:	No

Summary for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;7.5MG
Approval Date:	Apr 11, 2012	TE:	AA	RLD:	No

Summary for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;10MG
Approval Date:	Apr 11, 2012	TE:	AA	RLD:	No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.