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Generated: July 26, 2017

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Details for New Drug Application (NDA): 062031

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NDA 062031 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Chartwell Life Sci, Hikma Intl Pharms, Impax Labs Inc, Watson Labs, Mutual Pharm, Halsey, Actavis Labs Fl Inc, Pvt Form, Mylan, Par Pharm, Actavis Elizabeth, Sun Pharm Inds, Vintage Pharms, Mylan Pharms Inc, Heritage Pharms Inc, Heather, Interpharm, Ivax Sub Teva Pharms, Mayne Pharma Inc, Superpharm, Caribe Holdings, Lannett, Ranbaxy, Medicis, Epic Pharma Llc, Pliva, Larken Labs, Amneal Pharms, West-ward Pharms Int, Warner Chilcott, and Prinston Inc, and is included in forty-eight NDAs. It is available from seventy-nine suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.

The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for NDA: 062031

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 062031

Ingredient-typeTetracyclines

Suppliers and Packaging for NDA: 062031

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE;ORAL 062031 ANDA Actavis Pharma, Inc. 0591-5440 0591-5440-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0591-5440-05)
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE;ORAL 062031 ANDA Actavis Pharma, Inc. 0591-5440 0591-5440-50 50 CAPSULE in 1 BOTTLE, PLASTIC (0591-5440-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Oct 13, 1982TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Queensland Health
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Citi
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US Department of Justice
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UBS

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.

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