FDA.reportPublic FDA data

Application 040560

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THEOPHYLLINETHEOPHYLLINETABLET, EXTENDED RELEASE; ORAL600MGNoNo
002THEOPHYLLINETHEOPHYLLINETABLET, EXTENDED RELEASE;ORAL600MGNoYes
003THEOPHYLLINETHEOPHYLLINETABLET, EXTENDED RELEASE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0486TheophyllineTheophyllineMylan Pharmaceuticals Inc.ANDACurrent
0378-0486TheophyllineTheophyllineMylan Pharmaceuticals Inc.ANDACurrent
0378-0486TheophyllineTheophyllineMylan Pharamceuticals Inc.ANDACurrent
0378-0487TheophyllineTheophyllineMylan Pharamceuticals Inc.ANDACurrent
0378-0487TheophyllineTheophyllineMylan Pharmaceuticals Inc.ANDACurrent
0378-0487TheophyllineTheophyllineMylan Pharmaceuticals Inc.ANDACurrent
29033-001TheophyllineTheophyllineNostrum Laboratories, Inc.ANDACurrent
29033-001TheophyllineTheophyllineNostrum Laboratories, Inc.ANDACurrent
29033-001TheophyllineTheophyllineNostrum Laboratories, Inc.ANDACurrent
29033-002TheophyllineTheophyllineNostrum Laboratories, Inc.ANDACurrent
29033-002TheophyllineTheophyllineNostrum Laboratories, Inc.ANDACurrent
29033-002TheophyllineTheophyllineNostrum Laboratories, Inc.ANDACurrent
51407-318TheophyllineTheophyllineGolden State Medical SupplyANDACurrent
51407-318TheophyllineTheophyllineGolden State Medical Supply, Inc.ANDACurrent
51407-318TheophyllineTheophyllineGolden State Medical Supply, Inc.ANDACurrent
51407-319TheophyllineTheophyllineGolden State Medical SupplyANDACurrent
51407-319TheophyllineTheophyllineGolden State Medical Supply, Inc.ANDACurrent
51407-319TheophyllineTheophyllineGolden State Medical Supply, Inc.ANDACurrent
68151-4210TheophyllineTheophyllineCarilion Materials ManagementANDACurrent