Orange Book product · Brand (NDA)
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
DOBUTAMINE HYDROCHLORIDE
At a glance
Oct 19, 1993
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 19, 1993
33 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DOBUTAMINE HYDROCHLORIDE
Strength
EQ 200MG BASE/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 020255
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1993DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%Brand (NDA)
NDA 020269 · HOSPIRA
- 1993DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 020201 · HOSPIRA
- —DOBUTREXBrand (NDA)
NDA 017820 · LILLY
- 2022DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216131 · SLATE RUN PHARMA
- 1998DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074545 · LUITPOLD
- 1998DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074995 · DR REDDYS
- 1998DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074279 · WATSON LABS INC
- 1996DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074634 · HOSPIRA
- 1996DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074381 · BAXTER HLTHCARE
- 1995DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074098 · TELIGENT
- 1995DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074292 · HOSPIRA
- 1994DOBUTAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074277 · HIKMA
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.
