FDA.reportPublic FDA data

Application 209357

Type
ANDA
Sponsor
MSN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINCAPSULE;ORAL25MGNoNo
002PREGABALINPREGABALINCAPSULE;ORAL50MGNoNo
003PREGABALINPREGABALINCAPSULE;ORAL75MGNoNo
004PREGABALINPREGABALINCAPSULE;ORAL100MGNoNo
005PREGABALINPREGABALINCAPSULE;ORAL150MGNoNo
006PREGABALINPREGABALINCAPSULE;ORAL200MGNoNo
007PREGABALINPREGABALINCAPSULE;ORAL225MGNoNo
008PREGABALINPREGABALINCAPSULE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5071PregabalinPregabalinA-S Medication SolutionsANDACurrent
50090-5071PregabalinPregabalinA-S Medication SolutionsANDACurrent
50090-5071PregabalinPregabalinA-S Medication SolutionsANDACurrent
69539-011PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-011PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-011PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-012PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-012PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-012PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-013PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-013PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-013PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-014PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-014PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-014PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-015PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-015PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-015PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-016PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-016PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-016PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-017PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-017PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-017PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-018PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-018PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-018PregabalinPregabalinMSN LABORATORIES PRIVATE LIMITEDANDACurrent
70518-2525PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2525PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2525PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2745PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2745PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2745PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2745PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2762PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2762PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2762PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2763PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2763PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-3345PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-3346PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-3346PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
72205-011PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-011PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-011PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-011PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-012PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-012PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-012PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-012PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-013PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-013PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-013PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-013PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-014PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-014PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-014PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-014PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-015PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-015PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-015PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-015PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-016PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-016PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-016PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-016PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-017PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-017PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-017PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-017PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-018PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-018PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-018PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
72205-018PregabalinPregabalinNovadoz Pharmaceuticals LLCANDACurrent
80425-0026LyricaPregabalin 50mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0026LyricaPregabalin 50mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0026PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0026PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0030LyricaPregabalin 75mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0030LyricaPregabalin 75mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent