FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Theophylline Extended Release Tablets and Capsules
Status: Resolved
»Duration of Shortage: 04/05/2016 - 04/13/2018
»Therapeutic Categories: Pediatric; Pulmonary/Allergy

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Alembic Pharmaceuticals (Revised 04/13/2018)

Company Contact Information:
908-393-9604

Presentation
  • 300 mg, bottle of 30 counts (NDC 62332-025-30)
  • 300 mg, bottle of 100 counts (NDC 62332-025-31)
  • 300 mg, bottle of 500 counts (NDC 62332-025-71)
  • 300 mg, bottle of 1000 counts (NDC 62332-025-91)
  • 450 mg, bottle of 30 counts (NDC 62332-026-30)
  • 450 mg, bottle of 100 counts (NDC 62332-026-31)
  • 450 mg, bottle of 500 counts (NDC 62332-026-71)
Note:
  • Available

Endo Pharmaceuticals, Inc. (Revised 04/13/2018)

Company Contact Information:
800-462-3636

Presentation
  • Supplied in bottles of 100 capsules 100 mg (NDC 52244-100-10)
  • Supplied in bottles of 100 capsules 200 mg (NDC 52244-200-10)
  • Supplied in bottles of 100 capsules 300 mg (NDC 52244-300-10)
  • Supplied in bottles of 100 capsules 400 mg (NDC 52244-400-10)
Note:
  • Available

Mylan Pharmaceuticals Inc. (Revised 04/13/2018)

Company Contact Information:
800-RXMYLAN (1-800-496-9526).

Presentation
  • Theophylline ER Tabs 400mg 100s (NDC 0378-0486-01)
  • Theophylline ER Tabs 600mg 100s (NDC 0378-0487-01)
Note:
  • Available

Rhodes Pharmaceuticals L.P. (Revised 04/13/2018)

Company Contact Information:
888-827-0616

Presentation
  • Theophylline (anhydrous) Extended-Release Tablets, 400 mg 100 Tablet Bottle (NDC 42858-701-01)
  • Theophylline (anhydrous) Extended-Release Tablets, 600 mg 100 Tablet Bottle (NDC 42858-702-01)
Note:
  • Available

Teva Pharmaceuticals (Revised 04/13/2018)

Company Contact Information:
800-545-8800

Presentation
  • 100 count, 100 mg (NDC 50111-0483-01)
  • 500 count, 100 mg (NDC 50111-0483-02)
  • 100 count, 200 mg (NDC 50111-0482-01)
  • 500 count, 200 mg (NDC 50111-0482-02)
  • 1000 count, 200 mg (NDC 50111-0482-03)
  • 100 count, 300 mg (NDC 50111-0459-01)
  • 500 count, 300 mg (NDC 50111-0459-02)
  • 1000 count, 300 mg (NDC 50111-0459-03)
  • 100 count, 450 mg (NDC 50111-0518-01)
Note:
  • Relaunch expected by June 2019

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