NDC 60505-6226

Atropine

Atropine Sulfate

Atropine is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Apotrex Corp.. The primary component is Atropine Sulfate.

Product ID60505-6226_3f065576-edb0-6257-97cf-6cf85e27c081
NDC60505-6226
Product TypeHuman Prescription Drug
Proprietary NameAtropine
Generic NameAtropine Sulfate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2021-11-26
Marketing CategoryANDA /
Application NumberANDA215624
Labeler NameApotrex Corp.
Substance NameATROPINE SULFATE
Active Ingredient Strength10 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 60505-6226-0

1 BOTTLE, DROPPER in 1 CARTON (60505-6226-0) > 2 mL in 1 BOTTLE, DROPPER
Marketing Start Date2021-11-26
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Atropine" or generic name "Atropine Sulfate"

NDCBrand NameGeneric Name
13985-606AtropineAtropine
17478-215AtropineAtropine
50090-3104AtropineAtropine
0065-0817atropine sulfateatropine sulfate
0404-9819ATROPINE SULFATEatropine sulfate
0404-9820Atropine SulfateAtropine Sulfate
0404-9821Atropine SulfateAtropine Sulfate
0404-9822Atropine SulfateAtropine Sulfate
0404-9823Atropine SulfateAtropine Sulfate
0404-9824Atropine SulfateAtropine Sulfate
0409-1630Atropine SulfateATROPINE SULFATE
0409-4910ATROPINE SULFATEATROPINE SULFATE
0409-4911ATROPINE SULFATEATROPINE SULFATE
0409-9630Atropine SulfateATROPINE SULFATE
0065-0303Isopto Atropineatropine sulfate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.