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Details for New Drug Application (NDA): 205003

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NDA 205003 describes PRESTALIA, which is a drug marketed by Symplmed Pharms Llc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the PRESTALIA profile page.

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

Summary for NDA: 205003

Tradename:
PRESTALIA
Applicant:
Symplmed Pharms Llc
Ingredient:
amlodipine besylate; perindopril arginine
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 205003

Suppliers and Packaging for NDA: 205003

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL 205003 NDA Symplmed Pharmaceuticals, LLC 61894-010 61894-010-02 90 TABLET in 1 BOTTLE, PLASTIC (61894-010-02)
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL 205003 NDA Symplmed Pharmaceuticals, LLC 61894-011 61894-011-02 90 TABLET in 1 BOTTLE, PLASTIC (61894-011-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE;3.5MG
Approval Date:Jan 21, 2015TE:RLD:No
Patent:6,696,481Patent Expiration:Apr 15, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERTENSION
Patent:7,846,961Patent Expiration:Oct 5, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERTENSION

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;7MG
Approval Date:Jan 21, 2015TE:RLD:No
Patent:6,696,481Patent Expiration:Apr 15, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERTENSION


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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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