Orange Book product · Generic (ANDA)
PREGABALIN
PREGABALIN
At a glance
Sep 30, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 2019
6 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
PREGABALIN
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 207799
Product number
007
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PREGABALIN
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- 2024PREGABALINGeneric (ANDA)
ANDA 205924 · MACLEODS PHARMS LTD
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ANDA 214322 · CHANGZHOU PHARM
- 2024PREGABALINGeneric (ANDA)
ANDA 208113 · REGCON HOLDINGS
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.
