Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075090
Company: BOSCOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;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
01/26/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75090ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075090_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/08/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

02/06/2006 SUPPL-7 Labeling

Label is not available on this site.

02/06/2006 SUPPL-6 Labeling

Label is not available on this site.

02/04/2003 SUPPL-3 Labeling

Label is not available on this site.

ACYCLOVIR

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 075677 APOTEX INC
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 075090 BOSCOGEN
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 201445 CADILA PHARMS LTD
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 206261 CARLSBAD TECHNOLOGY
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 074833 DAVA PHARMS INC
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 074578 TEVA
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;ORAL Prescription No AB 204313 ZYDUS PHARMS USA INC
ZOVIRAX ACYCLOVIR 200MG CAPSULE;ORAL Prescription Yes AB 018828 MYLAN PHARMS INC

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