Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213583
Company: SPECGX LLC
Company: SPECGX LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | AA | No | No |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | 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 |
---|---|---|---|---|---|---|---|
01/22/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/18/2023 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/25/2022 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
AMPHETAMINE SULFATE
TABLET;ORAL; 5MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 213720 | ALKEM LABS LTD |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 211139 | AMNEAL PHARMS |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 211639 | AUROLIFE PHARMA LLC |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 212919 | BIONPHARMA |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 212582 | CEROVENE INC |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 213980 | EPIC PHARMA LLC |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 212619 | GRANULES |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 211861 | PRINSTON INC |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 213852 | RHODES PHARMS |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 212901 | SENORES PHARMS |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 213583 | SPECGX LLC |
EVEKEO | AMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 200166 | AZURITY |
TABLET;ORAL; 10MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 213720 | ALKEM LABS LTD |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 211139 | AMNEAL PHARMS |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 211639 | AUROLIFE PHARMA LLC |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 212919 | BIONPHARMA |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 212582 | CEROVENE INC |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 213980 | EPIC PHARMA LLC |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 212619 | GRANULES |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 211861 | PRINSTON INC |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 213852 | RHODES PHARMS |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 212901 | SENORES PHARMS |
AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 213583 | SPECGX LLC |
EVEKEO | AMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 200166 | AZURITY |