Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 212418
Company: ELITE LABS INC
Company: ELITE LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | AA | No | No |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | AA | No | No |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/10/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ACETAMINOPHEN AND CODEINE PHOSPHATE
TABLET;ORAL; 300MG;15MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 211610 | EYWA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 088627 | TEVA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 089990 | VINTAGE |
TABLET;ORAL; 300MG;30MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 040779 | AMNEAL PHARMS NY |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 211610 | EYWA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 085868 | SUN PHARM INDS LTD |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 088628 | TEVA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 089805 | VINTAGE |
| TYLENOL W/ CODEINE NO. 3 | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 085055 | JANSSEN PHARMS |
TABLET;ORAL; 300MG;60MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 211610 | EYWA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 087083 | SUN PHARM INDS LTD |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 088629 | TEVA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 089828 | VINTAGE PHARMS |
| TYLENOL W/ CODEINE NO. 4 | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 085055 | JANSSEN PHARMS |
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