Orange Book product · Generic (ANDA)
THEOPHYLLINE
THEOPHYLLINE
At a glance
Mar 26, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 26, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
THEOPHYLLINE
Strength
300MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 218401
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of THEOPHYLLINE
- 1995THEOPHYLLINEGeneric (ANDA)
ANDA 089976 · HOSPIRA
- 1995THEOPHYLLINEGeneric (ANDA)
ANDA 089977 · HOSPIRA
- 1995THEOPHYLLINEGeneric (ANDA)
ANDA 089932 · HOSPIRA
- 1994THEOPHYLLINEGeneric (ANDA)
ANDA 040052 · INWOOD LABS
- 1989SLO-BIDGeneric (ANDA)
ANDA 089539 · SANOFI AVENTIS US
- 1989SLO-BIDGeneric (ANDA)
ANDA 089540 · SANOFI AVENTIS US
- 1988THEOPHYLLINEGeneric (ANDA)
ANDA 089223 · ALPHARMA US PHARMS
- 1986AEROLATE IIIGeneric (ANDA)
ANDA 085075 · FLEMING PHARMS
- 1986THEOPHYLLINEGeneric (ANDA)
ANDA 084731 · SCHERER RP
- 1986THEOPHYLLINE-SRGeneric (ANDA)
ANDA 088255 · SCHERER RP
- 1985THEO-DURGeneric (ANDA)
ANDA 088022 · SCHERING
- 1985THEO-DURGeneric (ANDA)
ANDA 088015 · SCHERING
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
