Approvals (Drugs@FDA)

TELMISARTAN AND HYDROCHLOROTHIAZIDE

MANKIND PHARMA · HYDROCHLOROTHIAZIDE, TELMISARTAN

ANDA218406Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA218406
Sponsor name
MANKIND PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250303
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    TELMISARTAN AND HYDROCHLOROTHIAZIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      HYDROCHLOROTHIAZIDE
      Strength
      12.5MG
    2. Name
      TELMISARTAN
      Strength
      80MG
  2. Product number
    003
    Reference drug
    No
    Brand name
    TELMISARTAN AND HYDROCHLOROTHIAZIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      HYDROCHLOROTHIAZIDE
      Strength
      25MG
    2. Name
      TELMISARTAN
      Strength
      80MG
  3. Product number
    001
    Reference drug
    No
    Brand name
    TELMISARTAN AND HYDROCHLOROTHIAZIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      HYDROCHLOROTHIAZIDE
      Strength
      12.5MG
    2. Name
      TELMISARTAN
      Strength
      40MG
Harmonized identifiers (openFDA)
Application number
ANDA218406
Brand name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Generic name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer name
Lifestar Pharma LLC
Product NDC
70756-315, 70756-316, 70756-317
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
TELMISARTAN, HYDROCHLOROTHIAZIDE
RxCUI
283316, 283317, 477130
SPL ID
70efda7e-0c71-4faf-be4e-ef281d7cc297
SPL set ID
0c1bd0f4-034e-486c-ae46-2855c8c9ebda
Package NDC
70756-315-30, 70756-315-31, 70756-315-99, 70756-316-30, 70756-316-99, 70756-316-31, 70756-317-30, 70756-317-99, 70756-317-31
Nui
N0000000070, N0000175561, N0000175359, N0000175419, M0471776
Pharm class moa
Angiotensin 2 Receptor Antagonists [MoA]
Pharm class epc
Angiotensin 2 Receptor Blocker [EPC], Thiazide Diuretic [EPC]
Pharm class pe
Increased Diuresis [PE]
Pharm class cs
Thiazides [CS]
UNII
U5SYW473RQ, 0J48LPH2TH
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.