Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016084
Company: CASPER PHARMA LLC
Company: CASPER PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZYLOPRIM | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZYLOPRIM | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | AB | Yes | No |
| ZYLOPRIM | ALLOPURINOL | 200MG | TABLET;ORAL | Prescription | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/19/1966 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/21/2023 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016084s048s051s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/016084Orig1s048,051,s052ltr.pdf | |
| 09/21/2023 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016084s048s051s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/016084Orig1s048,051,s052ltr.pdf | |
| 08/04/2022 | SUPPL-49 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016084Orig1s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/016084Orig1s049ltr.pdf | ||
| 09/21/2023 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016084s048s051s052lbl.pdf | |
| 12/03/2018 | SUPPL-44 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016084s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016084s044ltr.pdf | |
| 07/17/2002 | SUPPL-41 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16084slr041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/016084_S041_Zyloprim Tablets.pdf |
| 07/11/1991 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1985 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1985 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1983 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/08/1982 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 01/27/1986 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1982 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/10/1982 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1982 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/25/1985 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 05/16/1989 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1980 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/30/1980 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/1977 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1976 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/16/1976 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/21/2023 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016084s048s051s052lbl.pdf | |
| 09/21/2023 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016084s048s051s052lbl.pdf | |
| 09/21/2023 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016084s048s051s052lbl.pdf | |
| 08/04/2022 | SUPPL-49 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016084Orig1s049lbl.pdf | |
| 12/03/2018 | SUPPL-44 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016084s044lbl.pdf |
ZYLOPRIM
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 203154 | ACCORD HLTHCARE |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077353 | CHARTWELL |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 214443 | HARMAN FINOCHEM |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 217748 | HETERO LABS LTD V |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 204467 | INDOCO |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 090637 | IPCA LABS LTD |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 018659 | MYLAN |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 078253 | NORTHSTAR HLTHCARE |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 071450 | SUN PHARM INDUSTRIES |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 211820 | UNICHEM |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 075798 | VINTAGE PHARMS |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 018832 | WATSON LABS |
| ALLOPURINOL | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 210117 | ZYDUS PHARMS |
| LOPURIN | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | No | AB | 071586 | DR REDDYS LA |
| ZYLOPRIM | ALLOPURINOL | 100MG | TABLET;ORAL | Prescription | Yes | AB | 016084 | CASPER PHARMA LLC |
TABLET;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 203154 | ACCORD HLTHCARE |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 077353 | CHARTWELL |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 214443 | HARMAN FINOCHEM |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 217748 | HETERO LABS LTD V |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 204467 | INDOCO |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 090637 | IPCA LABS LTD |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 018659 | MYLAN |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 078253 | NORTHSTAR HLTHCARE |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 071450 | SUN PHARM INDUSTRIES |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 211820 | UNICHEM |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 075798 | VINTAGE PHARMS |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 018877 | WATSON LABS |
| ALLOPURINOL | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 210117 | ZYDUS PHARMS |
| LOPURIN | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | No | AB | 071587 | DR REDDYS LA |
| ZYLOPRIM | ALLOPURINOL | 300MG | TABLET;ORAL | Prescription | Yes | AB | 016084 | CASPER PHARMA LLC |