Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210758
Company: SPECGX LLC
Company: SPECGX LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | AA | No | No |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
04/30/2018 | 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 |
---|---|---|---|---|---|
01/24/2019 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
01/24/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
OXYCODONE HYDROCHLORIDE
SOLUTION;ORAL; 5MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 208593 | ABHAI LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 211748 | ALKEM LABS LTD |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 204979 | ANI PHARMS |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 209021 | ASCENT PHARMS INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 200535 | GENUS LIFESCIENCES |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 204037 | HIKMA |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 206914 | PHARM ASSOC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 213761 | QUAGEN |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 210758 | SPECGX LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 207511 | WES PHARMA INC |
SOLUTION;ORAL; 100MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 208593 | ABHAI LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 211749 | ALKEM LABS LTD |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 209021 | ASCENT PHARMS INC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 200535 | GENUS LIFESCIENCES |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 206822 | PHARM ASSOC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 213761 | QUAGEN |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 210758 | SPECGX LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 209897 | WES PHARMA INC |