Approvals (Drugs@FDA)

ATORVASTATIN CALCIUM

MACLEODS PHARMS · ATORVASTATIN CALCIUM

ANDA208480Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA208480
Sponsor name
MACLEODS PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240603
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    004
    Reference drug
    No
    Brand name
    ATORVASTATIN CALCIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ATORVASTATIN CALCIUM
      Strength
      EQ 80MG BASE
  2. Product number
    002
    Reference drug
    No
    Brand name
    ATORVASTATIN CALCIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ATORVASTATIN CALCIUM
      Strength
      EQ 20MG BASE
  3. Product number
    003
    Reference drug
    No
    Brand name
    ATORVASTATIN CALCIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ATORVASTATIN CALCIUM
      Strength
      EQ 40MG BASE
  4. Product number
    001
    Reference drug
    No
    Brand name
    ATORVASTATIN CALCIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ATORVASTATIN CALCIUM
      Strength
      EQ 10MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA208480
Brand name
ATORVASTATIN CALCIUM
Generic name
ATORVASTATIN CALCIUM
Manufacturer name
Macleods Pharmaceuticals Limited
Product NDC
33342-315, 33342-316, 33342-317, 33342-318
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
ATORVASTATIN CALCIUM TRIHYDRATE
RxCUI
259255, 617310, 617311, 617312
SPL ID
227d544e-2777-4da2-a626-65fa8d62209a
SPL set ID
7bd0f0ec-f7a3-4403-9a1a-11f18213631f
Package NDC
33342-315-10, 33342-315-15, 33342-315-12, 33342-315-11, 33342-315-44, 33342-316-10, 33342-316-15, 33342-316-12, 33342-316-11, 33342-316-44, 33342-317-10, 33342-317-15, 33342-317-12, 33342-317-11, 33342-317-44, 33342-318-10, 33342-318-15, 33342-318-12, 33342-318-11, 33342-318-44
UNII
48A5M73Z4Q
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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.