Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213046
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
07/01/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
CAPSULE;ORAL; 300MG;50MG;40MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 210817 | DR REDDYS LABS SA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 213321 | GRANULES |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 212082 | LANNETT CO INC |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 040885 | LGM PHARMA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 215047 | NOVAST LABS |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 207118 | NUVO PHARMS INC |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 214288 | QUAGEN |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 214087 | SENORES PHARMS |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 213046 | TARO |