Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075231
Company: LGM PHARMA
Company: LGM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/30/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75231ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/12/2024 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
02/12/2024 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/12/2024 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-8 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
02/12/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
11/20/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
08/20/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/17/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
12/17/2002 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
CAPSULE;ORAL; 325MG;50MG;40MG;30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | No | AB | 075231 | LGM PHARMA |
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | No | AB | 074951 | STEVENS J |