FDA.reportPublic FDA data

Application 077626

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAMIPRILRAMIPRILCAPSULE;ORAL1.25MGNoNo
002RAMIPRILRAMIPRILCAPSULE;ORAL2.5MGNoNo
003RAMIPRILRAMIPRILCAPSULE;ORAL5MGNoNo
004RAMIPRILRAMIPRILCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-303RamiprilRamiprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-502RamiprilRamiprilPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3059RamiprilRamiprilA-S Medication SolutionsANDACurrent
50090-3059RamiprilRamiprilA-S Medication SolutionsANDACurrent
50090-4597RamiprilRamiprilA-S Medication SolutionsANDACurrent
50090-4597RamiprilRamiprilA-S Medication SolutionsANDACurrent
50090-4691RamiprilRamiprilA-S Medication SolutionsANDACurrent
50090-4691RamiprilRamiprilA-S Medication SolutionsANDACurrent
51655-144RamiprilRamiprilNorthwind PharmaceuticalsANDACurrent
51655-144RamiprilRamiprilNorthwind PharmaceuticalsANDACurrent
51655-346RamiprilRamiprilNorthwind PharmaceuticalsANDACurrent
51655-346RamiprilRamiprilNorthwind PharmaceuticalsANDACurrent
51655-347RamiprilRamiprilNorthwind PharmaceuticalsANDACurrent
51655-347RamiprilRamiprilNorthwind PharmaceuticalsANDACurrent
55700-551RamiprilRamiprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-551RamiprilRamiprilLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-157RAMIPRILRAMIPRILDIRECT RXANDACurrent
61919-157RAMIPRILRAMIPRILDIRECT RXANDACurrent
63187-073RamiprilRamiprilProficient Rx LPANDACurrent
63187-073RamiprilRamiprilProficient Rx LPANDACurrent
63187-073RamiprilRamiprilProficient Rx LPANDACurrent
63187-073RamiprilRamiprilProficient Rx LPANDACurrent
63187-277RamiprilRamiprilProficient Rx LPANDACurrent
63187-277RamiprilRamiprilProficient Rx LPANDACurrent
63187-277RamiprilRamiprilProficient Rx LPANDACurrent
63187-277RamiprilRamiprilProficient Rx LPANDACurrent
63187-503RamiprilRamiprilProficient Rx LPANDACurrent
63187-503RamiprilRamiprilProficient Rx LPANDACurrent
63187-503RamiprilRamiprilProficient Rx LPANDACurrent
68180-588RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-588RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-589RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-589RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-589RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-589RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-590RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-590RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-590RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-590RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-591RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-591RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-591RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-591RamiprilRamiprilLupin Pharmaceuticals, Inc.ANDACurrent
70934-410RamiprilRamiprilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-438RamiprilRamiprilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-496RamiprilRamiprilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44360ORIG2008-07-01
31267ORIG2008-06-10