Approvals (Drugs@FDA)

LEVOTHYROXINE SODIUM

ONESOURCE SPECIALTY · LEVOTHYROXINE SODIUM

ANDA216729Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216729
Sponsor name
ONESOURCE SPECIALTY
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250305
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    LEVOTHYROXINE SODIUM
    Reference standard
    No
    Dosage form
    POWDER
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      LEVOTHYROXINE SODIUM
      Strength
      500MCG/VIAL
  2. Product number
    001
    Reference drug
    No
    Brand name
    LEVOTHYROXINE SODIUM
    Reference standard
    No
    Dosage form
    POWDER
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      LEVOTHYROXINE SODIUM
      Strength
      100MCG/VIAL
  3. Product number
    002
    Reference drug
    No
    Brand name
    LEVOTHYROXINE SODIUM
    Reference standard
    No
    Dosage form
    POWDER
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      LEVOTHYROXINE SODIUM
      Strength
      200MCG/VIAL
Harmonized identifiers (openFDA)
Application number
ANDA216729
Brand name
LEVOTHYROXINE SODIUM
Generic name
LEVOTHYROXINE SODIUM ANHYDROUS
Manufacturer name
Fosun Pharma USA Inc., ONESOURCE SPECIALTY PHARMA LIMITED
Product NDC
72266-261, 83270-006, 83270-008, 83270-007
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
LEVOTHYROXINE SODIUM ANHYDROUS
RxCUI
1115267, 966219, 1115269
SPL ID
53ff60de-4131-c23e-e063-6394a90a34ba, 58da3dc9-3dea-30eb-e063-6294a90ad6ea
SPL set ID
3361138a-6e6f-e8df-e063-6294a90af2de, ae9954a5-e196-449c-abea-ebe4afbee517
Package NDC
72266-261-01, 83270-008-01, 83270-007-01, 83270-006-01
UNII
054I36CPMN
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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.