Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075274
Company: ELITE LABS
Company: ELITE LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/26/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75274ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75274_Naltrexone.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/21/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
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 |