Approvals (Drugs@FDA)

SACUBITRIL AND VALSARTAN

LAURUS · SACUBITRIL, VALSARTAN

ANDA213676Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA213676
Sponsor name
LAURUS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240528
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      78591
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213676Orig1s000ltr.pdf
      Date
      20240531
      Type
      Letter
    2. ID
      84213
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/213676Orig1s000.pdf
      Date
      20251119
      Type
      Review
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    SACUBITRIL AND VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      SACUBITRIL
      Strength
      97MG
    2. Name
      VALSARTAN
      Strength
      103MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    SACUBITRIL AND VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      SACUBITRIL
      Strength
      24MG
    2. Name
      VALSARTAN
      Strength
      26MG
  3. Product number
    002
    Reference drug
    No
    Brand name
    SACUBITRIL AND VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      SACUBITRIL
      Strength
      49MG
    2. Name
      VALSARTAN
      Strength
      51MG
Harmonized identifiers (openFDA)
Application number
ANDA213676
Brand name
SACUBITRIL AND VALSARTAN
Generic name
SACUBITRIL AND VALSARTAN
Manufacturer name
Laurus Labs Limited, ANI Pharmaceuticals, Inc.
Product NDC
42385-930, 42385-931, 42385-932, 70954-975, 70954-976, 70954-977
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
SACUBITRIL, VALSARTAN
RxCUI
1656340, 1656349, 1656354
SPL ID
b47b5c7e-1c20-429c-9560-07f5f06cdce3, fb8d85f8-7a85-422b-82f0-2a4f5d296b07
SPL set ID
b47b5c7e-1c20-429c-9560-07f5f06cdce3, a1fa7066-8ab4-47e3-a701-6c5170700d11
Package NDC
42385-930-30, 42385-930-60, 42385-930-18, 42385-930-10, 42385-930-68, 42385-930-17, 42385-930-72, 42385-931-30, 42385-931-60, 42385-931-18, 42385-931-10, 42385-931-68, 42385-931-17, 42385-931-72, 42385-932-30, 42385-932-60, 42385-932-18, 42385-932-10, 42385-932-68, 42385-932-17, 42385-932-72, 70954-975-20, 70954-975-30, 70954-975-50, 70954-976-20, 70954-976-30, 70954-976-50, 70954-977-20, 70954-977-30, 70954-977-50
Nui
N0000000070, N0000175561
Pharm class moa
Angiotensin 2 Receptor Antagonists [MoA]
Pharm class epc
Angiotensin 2 Receptor Blocker [EPC]
UNII
80M03YXJ7I, 17ERJ0MKGI
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.