Orange Book product · Brand (NDA)
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
THEOPHYLLINE
At a glance
Nov 07, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 07, 1984
42 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
THEOPHYLLINE
Strength
40MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019083
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 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.

