Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076264
Company: SPECGX LLC
Company: SPECGX LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | None | No | No |
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | No | Yes |
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
03/22/2002 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76264.APD.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076264_S000_ORIGINAL APPROVAL_PACKAGE.pdf |
NALTREXONE HYDROCHLORIDE
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 091205 | ACCORD HLTHCARE |
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 074918 | BARR |
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 207905 | CHARTWELL |
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 075274 | ELITE LABS |
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 076264 | SPECGX LLC |
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 090356 | SUN PHARM |