Drugs@FDA: FDA-Approved Drugs
Company: BARR
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 |
---|---|---|---|---|---|---|---|
05/08/1998 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74918ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74918.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/02/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
09/02/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
11/20/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
04/19/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/29/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
09/14/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
12/21/1999 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
11/22/1999 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
11/22/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/20/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/22/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/01/1998 | SUPPL-1 | Manufacturing (CMC) |
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 |