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. 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. Eighteen 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:	0

Pharmacology for NDA: 019901

Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for 019901

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

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:	RX	Dosage:	CAPSULE;ORAL			Strength	1.25MG
Approval Date:	Jan 28, 1991	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2.5MG
Approval Date:	Jan 28, 1991	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Jan 28, 1991	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019901

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991	5,061,722	⤷ Subscribe
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991	5,061,722	⤷ Subscribe
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-002	Jan 28, 1991	4,587,258	⤷ Subscribe
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991	4,587,258	⤷ Subscribe
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-001	Jan 28, 1991	4,587,258	⤷ Subscribe
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