Approvals (Drugs@FDA)

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

LGM PHARMA · ASPIRIN, BUTALBITAL, CAFFEINE +1

ANDA075231Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA075231
Sponsor name
LGM PHARMA
Submissions
  1. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20020820
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20021217
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  3. Submission type
    SUPPL
    Submission number
    16
    Submission status
    AP
    Submission status date
    20260618
    Submission class code
    REMS
    Submission class code description
    REMS
  4. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    20180918
    Submission class code
    REMS
    Submission class code description
    REMS
  5. Submission type
    SUPPL
    Submission number
    14
    Submission status
    AP
    Submission status date
    20251222
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  6. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20151120
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  7. Submission type
    SUPPL
    Submission number
    12
    Submission status
    AP
    Submission status date
    20241031
    Submission class code
    REMS
    Submission class code description
    REMS
  8. Submission type
    SUPPL
    Submission number
    10
    Submission status
    AP
    Submission status date
    20240212
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  9. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20021217
    Submission class code
    LABELING
    Submission class code description
    Labeling
  10. Submission type
    SUPPL
    Submission number
    9
    Submission status
    AP
    Submission status date
    20240212
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  11. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20240212
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  12. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    20250509
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  13. +2 more not shown
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ASPIRIN
      Strength
      325MG
    2. Name
      BUTALBITAL
      Strength
      50MG
    3. Name
      CAFFEINE
      Strength
      40MG
    4. Name
      CODEINE PHOSPHATE
      Strength
      30MG
Harmonized identifiers (openFDA)
Application number
ANDA075231
Brand name
ASCOMP WITH CODEINE
Generic name
BUTALBITAL, ASPIRIN, CAFEINE, AND CODEINE PHOSPHATE, BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE
Manufacturer name
LGM PHARMA SOLUTIONS, LLC, Breckenridge Pharmaceutical, Inc.
Product NDC
79739-6094, 51991-074
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
BUTALBITAL, ASPIRIN, CAFFEINE, CODEINE PHOSPHATE
RxCUI
994237, 994239
SPL ID
e8714e9d-80cc-4c5e-b469-67ce10256d85, a41a61f0-e530-4fb5-8198-bdc866219e33
SPL set ID
1cab3106-1064-4b42-892b-39f405d9e02f, 243a6aea-0f48-42a9-a85e-ff247ab94336
Package NDC
79739-6094-1, 51991-074-01, 51991-074-05
Nui
N0000175693, M0002177, N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832, N0000175739, N0000175729, N0000175790, M0023046
Pharm class epc
Barbiturate [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Central Nervous System Stimulant [EPC], Methylxanthine [EPC]
Pharm class cs
Barbiturates [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]
Pharm class moa
Cyclooxygenase Inhibitors [MoA]
Pharm class pe
Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Central Nervous System Stimulation [PE]
UNII
KHS0AZ4JVK, R16CO5Y76E, 3G6A5W338E, GSL05Y1MN6
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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.