FDA Orange Book · active-ingredient family
Atropine
Atropine: 2 brands, 1 generic; first approved Jan 30, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
2
Generics (ANDA)
1
Listed patents
0
Presentations
6
Brand (NDA) products
Originator applications
- ATROPENRLDMMTNDA 01710620044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG SULFATE/0.7ML SOLUTION INTRAMUSCULAR Discontinued — EQ 1MG SULFATE/0.7ML SOLUTION INTRAMUSCULAR Discontinued — EQ 0.5MG SULFATE/0.7ML SOLUTION INTRAMUSCULAR Discontinued — EQ 0.25MG SULFATE/0.3ML SOLUTION INTRAMUSCULAR Discontinued — - RAFA LABS LTDNDA 2123192018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION INTRAMUSCULAR Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- ATROPINEABBVIEANDA 0712951987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG SULFATE/0.7ML SOLUTION INTRAMUSCULAR Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
40 yr 1 mo ago
Most recent approval
8 yr 3 mo ago
Approvals span 1987–2018 across 3 FDA applications.
Brand (NDA) 267%
Generic (ANDA) 133%
Atropine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
