Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083900
Company: SMITH KLINE & FRENCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENZEDRINE AMPHETAMINE SULFATE 5MG Tablet; Oral Discontinued None No No
BENZEDRINE AMPHETAMINE SULFATE 10MG Tablet; 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
02/26/1976 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083900_amphetamine-sulfate_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/11/1981 SUPPL-9 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S9.pdf
12/14/1979 SUPPL-8 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S8.pdf
05/11/1982 SUPPL-7 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S7.pdf
02/06/1979 SUPPL-6 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S6.pdf
02/11/1981 SUPPL-5 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S5.pdf
11/21/1978 SUPPL-4 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S4.pdf
11/21/1978 SUPPL-3 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S3.pdf
05/11/1977 SUPPL-2 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S2.pdf
04/15/1976 SUPPL-1 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S1.pdf

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