Details for New Drug Application (NDA): 206289
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The generic ingredient in ATROPINE SULFATE is atropine sulfate. There are twenty-three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.
Summary for 206289
Tradename: | ATROPINE SULFATE |
Applicant: | Rising |
Ingredient: | atropine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206289
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 206289 | NDA AUTHORIZED GENERIC | Akorn | 76478-015 | 76478-015-02 | 1 BOTTLE, DROPPER in 1 CARTON (76478-015-02) / 2 mL in 1 BOTTLE, DROPPER |
ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 206289 | NDA AUTHORIZED GENERIC | Akorn | 76478-015 | 76478-015-05 | 1 BOTTLE, DROPPER in 1 CARTON (76478-015-05) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
Approval Date: | Jul 18, 2014 | TE: | AT | RLD: | Yes |
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