Orange Book product · Brand (NDA)
PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PROPRANOLOL HYDROCHLORIDE
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 016419
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
- 2003INNOPRAN XLBrand (NDA)
NDA 021438 · ANI PHARMS
- 1987INDERAL LABrand (NDA)
NDA 018553 · ANI PHARMS
- 1986INDERALBrand (NDA)
NDA 019536 · WYETH AYERST
- —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.
