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Generated: January 23, 2019

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Details for New Drug Application (NDA): 019901

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NDA 019901 describes ALTACE, which is a drug marketed by King Pharms Llc and King Pfizer and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ALTACE profile page.

The generic ingredient in ALTACE is ramipril. There are nineteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the ramipril profile page.
Summary for 019901
Tradename:ALTACE
Applicant:King Pharms Llc
Ingredient:ramipril
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 019901
Medical Subject Heading (MeSH) Categories for 019901
Suppliers and Packaging for NDA: 019901
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALTACE ramipril CAPSULE;ORAL 019901 NDA Pfizer Laboratories Div Pfizer Inc 61570-110 61570-110-01 100 CAPSULE in 1 BOTTLE (61570-110-01)
ALTACE ramipril CAPSULE;ORAL 019901 NDA Pfizer Laboratories Div Pfizer Inc 61570-111 61570-111-01 100 CAPSULE in 1 BOTTLE (61570-111-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1.25MG
Approval Date:Jan 28, 1991TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 30, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jan 28, 1991TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 30, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jan 28, 1991TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 30, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH

Expired US Patents for NDA 019901

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms Llc ALTACE ramipril CAPSULE;ORAL 019901-004 Jan 28, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
King Pharms Llc ALTACE ramipril CAPSULE;ORAL 019901-004 Jan 28, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
King Pharms Llc ALTACE ramipril CAPSULE;ORAL 019901-001 Jan 28, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
King Pharms Llc ALTACE ramipril CAPSULE;ORAL 019901-003 Jan 28, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
King Pharms Llc ALTACE ramipril CAPSULE;ORAL 019901-002 Jan 28, 1991 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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