Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206615
Company: XSPIRE PHARMA
Company: XSPIRE PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 08/04/2017 | 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 | 213321 | GRANULES PHARMS |
| 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 | 210817 | MAYNE PHARMA INC |
| 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 | 213046 | TARO PHARM INDS LTD |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE;ORAL | Prescription | No | AA | 206615 | XSPIRE PHARMA |
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