Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016084
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 Yes
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
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.

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 APOTEX INC
ALLOPURINOL ALLOPURINOL 100MG TABLET;ORAL Prescription No AB 204467 INDOCO REMEDIES
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 078390 SUN PHARM INDS INC
ALLOPURINOL ALLOPURINOL 100MG TABLET;ORAL Prescription No AB 071450 SUN PHARM INDUSTRIES
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 USA INC
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 APOTEX INC
ALLOPURINOL ALLOPURINOL 300MG TABLET;ORAL Prescription No AB 204467 INDOCO REMEDIES
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 078390 SUN PHARM INDS INC
ALLOPURINOL ALLOPURINOL 300MG TABLET;ORAL Prescription No AB 071450 SUN PHARM INDUSTRIES
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 USA INC
LOPURIN ALLOPURINOL 300MG TABLET;ORAL Prescription No AB 071587 DR REDDYS LA
ZYLOPRIM ALLOPURINOL 300MG TABLET;ORAL Prescription Yes AB 016084 CASPER PHARMA LLC

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