Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213115
Company: GRANULES
Company: GRANULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 300MG;50MG | 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 |
---|---|---|---|---|---|---|---|
11/22/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213115Orig1s000ltr.pdf |
BUTALBITAL AND ACETAMINOPHEN
CAPSULE;ORAL; 300MG;50MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 300MG;50MG | CAPSULE;ORAL | Prescription | No | AA | 207313 | DR REDDYS LABS SA |
BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 300MG;50MG | CAPSULE;ORAL | Prescription | No | AA | 213115 | GRANULES |