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FDA Approval

Ramipril

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 26, 2023
Labeling Type
Human Prescription Drug Label
Ramipril(10 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ramipril

Product Details

NDC Product Code
50090-1120
Application Number
ANDA091604
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 8, 2022
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
RamiprilActive
Code: L35JN3I7SJClass: ACTIBQuantity: 10 mg in 1 1
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT

Ramipril

Product Details

NDC Product Code
50090-1118
Application Number
ANDA091604
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 8, 2022
RamiprilActive
Code: L35JN3I7SJClass: ACTIBQuantity: 5 mg in 1 1
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
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