FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Theophylline Extended Release Tablets and Capsules
Status: Currently in Shortage
»Date first posted: 04/05/2016
»Therapeutic Categories: Pediatric; Pulmonary/Allergy

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Alembic Pharmaceuticals (New 04/05/2016)

Company Contact Information:
908-393-9604

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
300 mg, bottle of 30 counts (NDC 62332-025-30) Product available Available Other
300 mg, bottle of 100 counts (NDC 62332-025-31) Product available Available Other
300 mg, bottle of 500 counts (NDC 62332-025-71) Product available Available Other
300 mg, bottle of 1000 counts (NDC 62332-025-91) Product available Available Other
450 mg, bottle of 30 counts (NDC 62332-026-30) Product available Available Other
450 mg, bottle of 100 counts (NDC 62332-026-31) Product available Available Other
450 mg, bottle of 500 counts (NDC 62332-026-71) Product available Available Other

Endo Pharmaceuticals, Inc. (New 04/07/2016)

Company Contact Information:
800-462-3636

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Supplied in bottles of 100 capsules 100 mg (NDC 52244-100-10) Available and able to meet demand. Available Other
Supplied in bottles of 100 capsules 200 mg (NDC 52244-200-10) Available and able to meet demand. Available Other
Supplied in bottles of 100 capsules 300 mg (NDC 52244-300-10) Available and able to meet demand. Available Other
Supplied in bottles of 100 capsules 400 mg (NDC 52244-400-10) Available and able to meet demand. Available Other

Mylan Pharmaceuticals Inc. (Reverified 09/12/2017)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Theophylline ER Tabs 400mg 100s (NDC 0378-0486-01) Available Other
Theophylline ER Tabs 600mg 100s (NDC 0378-0487-01) Available Other

Rhodes Pharmaceuticals L.P. (Revised 04/11/2016)

Company Contact Information:
888-827-0616

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Theophylline (anhydrous) Extended-Release Tablets, 400 mg 100 Tablet Bottle (NDC 42858-701-01) Available Available Other
Theophylline (anhydrous) Extended-Release Tablets, 600 mg 100 Tablet Bottle (NDC 42858-702-01) Available Available Other

Teva Pharmaceuticals (Reverified 04/21/2017)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
100 count, 100 mg (NDC 50111-0483-01) Estimated availability: 2Q 2018 Requirements related to complying with good manufacturing practices
500 count, 100 mg (NDC 50111-0483-02) Estimated availability: 2Q 2018 Requirements related to complying with good manufacturing practices
100 count, 200 mg (NDC 50111-0482-01) Estimated availability: 2Q 2018 Requirements related to complying with good manufacturing practices
500 count, 200 mg (NDC 50111-0482-02) Estimated availability: 2Q 2018 Requirements related to complying with good manufacturing practices
1000 count, 200 mg (NDC 50111-0482-03) Estimated availability: 2Q 2018 Requirements related to complying with good manufacturing practices
100 count, 300 mg (NDC 50111-0459-01) Estimated availability: 2Q 2018 Requirements related to complying with good manufacturing practices
500 count, 300 mg (NDC 50111-0459-02) Estimated availability: 2Q 2018 Requirements related to complying with good manufacturing practices
1000 count, 300 mg (NDC 50111-0459-03) Estimated availability: 2Q 2018 Requirements related to complying with good manufacturing practices
100 count, 450 mg (NDC 50111-0518-01) Estimated availability: 2Q 2018 Requirements related to complying with good manufacturing practices

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