Approvals (Drugs@FDA)

LISINOPRIL AND HYDROCHLOROTHIAZIDE

INVAGEN PHARMS · HYDROCHLOROTHIAZIDE, LISINOPRIL

ANDA204058Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA204058
Sponsor name
INVAGEN PHARMS
Submissions
  1. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20240531
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20200807
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20170523
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    LISINOPRIL AND HYDROCHLOROTHIAZIDE
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      HYDROCHLOROTHIAZIDE
      Strength
      12.5MG
    2. Name
      LISINOPRIL
      Strength
      20MG
  2. Product number
    003
    Reference drug
    No
    Brand name
    LISINOPRIL AND HYDROCHLOROTHIAZIDE
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      HYDROCHLOROTHIAZIDE
      Strength
      25MG
    2. Name
      LISINOPRIL
      Strength
      20MG
  3. Product number
    001
    Reference drug
    No
    Brand name
    LISINOPRIL AND HYDROCHLOROTHIAZIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      HYDROCHLOROTHIAZIDE
      Strength
      12.5MG
    2. Name
      LISINOPRIL
      Strength
      10MG
Harmonized identifiers (openFDA)
Application number
ANDA204058
Brand name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Generic name
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS
Manufacturer name
Exelan Pharmaceuticals, Inc., Cipla USA Inc.
Product NDC
76282-446, 76282-447, 76282-448, 69097-968, 69097-969, 69097-971
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
LISINOPRIL, HYDROCHLOROTHIAZIDE
RxCUI
197885, 197886, 197887
SPL ID
7f4a4f31-58b0-4fe1-bd11-ba5a6ac4f26c, 2815b0ef-9835-4b49-b98d-8519e7005dc1
SPL set ID
c40b15ec-6083-4778-bca8-3e895e5694e1, 40e6b627-63dc-4d52-aaa8-750663ad86c2
Package NDC
76282-446-90, 76282-446-01, 76282-446-05, 76282-446-10, 76282-447-90, 76282-447-01, 76282-447-05, 76282-447-10, 76282-448-90, 76282-448-01, 76282-448-05, 76282-448-10, 69097-968-05, 69097-968-07, 69097-968-12, 69097-968-15, 69097-969-05, 69097-969-07, 69097-969-12, 69097-969-15, 69097-971-05, 69097-971-07, 69097-971-12, 69097-971-15
Nui
N0000175359, N0000175419, M0471776
Pharm class pe
Increased Diuresis [PE]
Pharm class epc
Thiazide Diuretic [EPC]
Pharm class cs
Thiazides [CS]
UNII
0J48LPH2TH, E7199S1YWR
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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.