Orange Book product · Brand (NDA)
INNOPRAN XL
PROPRANOLOL HYDROCHLORIDE
At a glance
Mar 12, 2003
Approved
Brand (NDA)
Application
BX
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 12, 2003
23 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
PROPRANOLOL HYDROCHLORIDE
Strength
120MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
BX
Application
NDA 021438
Product number
002
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.
- 2014HEMANGEOLBrand (NDA)
NDA 205410 · ETON
- 1987INDERAL LABrand (NDA)
NDA 018553 · ANI PHARMS
- 1986INDERALBrand (NDA)
NDA 019536 · WYETH AYERST
- —PROPRANOLOL HYDROCHLORIDEBrand (NDA)
NDA 016419 · BAXTER HLTHCARE CORP
- —INDERALBrand (NDA)
NDA 016418 · WYETH PHARMS
- 2026PROPRANOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 219165 · PAI HOLDINGS
- 2026PROPRANOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 203103 · IPCA LABS LTD
- 2024PROPRANOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 204349 · LUPIN
- 2020PROPRANOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 212026 · AMTA
- 2011PROPRANOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 078703 · ADARE PHARMS INC
- 2011PROPRANOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 090321 · ZYDUS PHARMS USA INC
- 2009PROPRANOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 078311 · UPSHER SMITH LABS
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.
