NDC 46708-193

Solifenacin Succinate

Solifenacin Succinate

Solifenacin Succinate is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Solifenacin Succinate.

Product ID46708-193_aea71cde-6d62-4f8d-b813-47064cb213d9
NDC46708-193
Product TypeHuman Prescription Drug
Proprietary NameSolifenacin Succinate
Generic NameSolifenacin Succinate
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-05-20
Marketing CategoryANDA / ANDA
Application NumberANDA205575
Labeler NameAlembic Pharmaceuticals Limited
Substance NameSOLIFENACIN SUCCINATE
Active Ingredient Strength10 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 46708-193-08

80 TABLET, COATED in 1 CARTON (46708-193-08)
Marketing Start Date2019-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-193-90 [46708019390]

Solifenacin Succinate TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205575
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

NDC 46708-193-30 [46708019330]

Solifenacin Succinate TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205575
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

NDC 46708-193-91 [46708019391]

Solifenacin Succinate TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205575
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

NDC 46708-193-08 [46708019308]

Solifenacin Succinate TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205575
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

Drug Details

Active Ingredients

IngredientStrength
SOLIFENACIN SUCCINATE10 mg/1

OpenFDA Data

SPL SET ID:aea71cde-6d62-4f8d-b813-47064cb213d9
Manufacturer
UNII
UPC Code
  • 0346708193300

    • Pharmacological Class

    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]
    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]

    NDC Crossover Matching brand name "Solifenacin Succinate" or generic name "Solifenacin Succinate"

    NDCBrand NameGeneric Name
    0093-5263Solifenacin SuccinateSolifenacin Succinate
    0093-5264Solifenacin SuccinateSolifenacin Succinate
    0591-3795Solifenacin succinatesolifenacin succinate
    0591-3796Solifenacin succinatesolifenacin succinate
    27241-037solifenacin succinatesolifenacin succinate
    27241-038solifenacin succinatesolifenacin succinate
    29300-328Solifenacin SuccinateSolifenacin Succinate
    29300-329Solifenacin SuccinateSolifenacin Succinate
    31722-027solifenacin succinatesolifenacin succinate
    31722-028solifenacin succinatesolifenacin succinate
    35561-285Solifenacin Succinatesolifenacin succiate
    35561-286Solifenacin Succinatesolifenacin succinate
    42291-739Solifenacin Succinatesolifenacin succiate
    42291-740Solifenacin Succinatesolifenacin succinate
    69539-051Solifenacin SuccinateSolifenacin Succinate
    69539-050Solifenacin SuccinateSolifenacin Succinate
    72205-020Solifenacin SuccinateSolifenacin Succinate
    72606-010solifenacin succinatesolifenacin succinate
    72606-009solifenacin succinatesolifenacin succinate
    72205-021Solifenacin SuccinateSolifenacin Succinate
    46708-193Solifenacin SuccinateSolifenacin Succinate
    46708-192Solifenacin SuccinateSolifenacin Succinate
    50228-427SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE
    50228-428SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE
    51407-227Solifenacin SuccinateSolifenacin Succinate
    51407-228Solifenacin SuccinateSolifenacin Succinate
    51991-893Solifenacin SuccinateSolifenacin Succinate
    51991-894Solifenacin SuccinateSolifenacin Succinate
    60505-4703Solifenacin SuccinateSolifenacin Succinate
    60505-4702Solifenacin SuccinateSolifenacin Succinate
    62332-192Solifenacin SuccinateSolifenacin Succinate
    62332-193Solifenacin SuccinateSolifenacin Succinate
    67877-527Solifenacin SuccinateSolifenacin Succinate
    67877-528Solifenacin SuccinateSolifenacin Succinate
    68462-387solifenacin succinatesolifenacin succinate
    68462-386solifenacin succinatesolifenacin succinate
    69238-1309Solifenacin SuccinateSolifenacin Succinate
    69238-1308Solifenacin SuccinateSolifenacin Succinate
    51407-254SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE
    51407-255SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE
    60687-499Solifenacin SuccinateSolifenacin Succinate
    69367-239Solifenacin SuccinateSolifenacin Succinate
    69367-240Solifenacin SuccinateSolifenacin Succinate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.