Orange Book product · Generic (ANDA)
PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE
At a glance
Jun 10, 2026
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 10, 2026
9 d ago
Today
Pharmaceutical detail
Active ingredient
PROPRANOLOL HYDROCHLORIDE
Strength
20MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 219165
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PROPRANOLOL HYDROCHLORIDE
- 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
- —PROPRANOLOL HYDROCHLORIDEBrand (NDA)
NDA 016419 · BAXTER HLTHCARE CORP
- —INDERALBrand (NDA)
NDA 016418 · WYETH PHARMS
- 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.
