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Details for New Drug Application (NDA): 040668

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NDA 040668 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Morton Grove, Pliva, Superpharm, Sandoz, Tg United Labs, Naska, Patrin Pharma Inc, Par Pharm, Duramed Pharms Barr, Actavis Mid Atlantic, Impax Labs Inc, Kv Pharm, Pioneer Pharms, Stason Pharms, Watson Labs, Appco Pharma Llc, Apnar Pharma Lp, Ivax Sub Teva Pharms, Halsey, Md Pharm, Lyne, Mylan, Apex Pharms Inc, Vitarine, Ascot, Ingenus Pharms Nj, Pharm Assoc, and Am Therap, and is included in thirty-one NDAs. It is available from twenty-one suppliers. Additional details are available on the CYPROHEPTADINE HYDROCHLORIDE profile page.

The generic ingredient in CYPROHEPTADINE HYDROCHLORIDE is cyproheptadine hydrochloride. There are six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

Summary for NDA: 040668

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 040668

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride
SYRUP;ORAL 040668 ANDA Actavis Mid Atlantic LLC 0472-1400 0472-1400-16 473 mL in 1 BOTTLE (0472-1400-16)
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride
SYRUP;ORAL 040668 ANDA Physicians Total Care, Inc. 54868-4338 54868-4338-0 473 mL in 1 BOTTLE (54868-4338-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength2MG/5ML
Approval Date:Jun 28, 2006TE:AARLD: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.

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