Approvals (Drugs@FDA)

BUTALBITAL AND ACETAMINOPHEN

QUAGEN · ACETAMINOPHEN, BUTALBITAL

ANDA214305Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA214305
Sponsor name
QUAGEN
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240201
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    BUTALBITAL AND ACETAMINOPHEN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AA
    Active ingredients
    1. Name
      ACETAMINOPHEN
      Strength
      300MG
    2. Name
      BUTALBITAL
      Strength
      50MG
Harmonized identifiers (openFDA)
Application number
ANDA214305
Brand name
BUTALBITAL AND ACETAMINOPHEN
Generic name
BUTALBITAL AND ACETAMINOPHEN
Manufacturer name
QUAGEN PHARMACEUTICALS LLC
Product NDC
70752-147
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
BUTALBITAL, ACETAMINOPHEN
RxCUI
1249617
SPL ID
1d75a5ef-9dbe-4e3b-bc91-ffc68c88b3af
SPL set ID
1f0dbe62-6aea-4323-ad25-c2211f919253
Package NDC
70752-147-10, 70752-147-14
Nui
N0000175693, M0002177
Pharm class epc
Barbiturate [EPC]
Pharm class cs
Barbiturates [CS]
UNII
KHS0AZ4JVK, 362O9ITL9D
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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.