Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074975
Company: RANBAXY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Discontinued 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
09/30/1998 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74975ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074975_acyclovir_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/10/2003 SUPPL-9 Labeling

Label is not available on this site.

04/18/2001 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/18/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/27/2000 SUPPL-4 Labeling

Label is not available on this site.

04/18/2001 SUPPL-3 Labeling

Label is not available on this site.

04/18/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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