PHENYLEPHRINE HYDROCHLORIDE
CAPLIN · PHENYLEPHRINE HYDROCHLORIDE
Open FDA's page for this record- Application number
- ANDA215183
- Sponsor name
- CAPLIN
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20240523
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 002
- Reference drug
- No
- Brand name
- PHENYLEPHRINE HYDROCHLORIDE
- Reference standard
- No
- Dosage form
- SOLUTION/DROPS
- Route
- OPHTHALMIC
- Marketing status
- Prescription
- Te code
- AT
- Active ingredients
- Name
- PHENYLEPHRINE HYDROCHLORIDE
- Strength
- 10%
- Product number
- 001
- Reference drug
- No
- Brand name
- PHENYLEPHRINE HYDROCHLORIDE
- Reference standard
- No
- Dosage form
- SOLUTION/DROPS
- Route
- OPHTHALMIC
- Marketing status
- Prescription
- Te code
- AT
- Active ingredients
- Name
- PHENYLEPHRINE HYDROCHLORIDE
- Strength
- 2.5%
- Harmonized identifiers (openFDA)
- Application number
- ANDA215183
- Brand name
- PHENYLEPHRINE HYDROCHLORIDE
- Generic name
- PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer name
- Caplin Steriles Limited, SOLA Pharmaceuticals, LLC, Leading Pharma, LLC
- Product NDC
- 65145-148, 65145-149, 65145-150, 70512-865, 70512-866, 69315-323, 69315-324
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- OPHTHALMIC
- Substance name
- PHENYLEPHRINE HYDROCHLORIDE
- RxCUI
- 1234571, 1234579
- SPL ID
- 606202d3-4976-427a-8ced-f8ae0c2a9a4c, 45728b25-194d-ddeb-e063-6294a90af4c9, a73191de-c6e0-455f-8e26-f90a529cac56
- SPL set ID
- 1b3eec91-5be5-4010-bf92-4c3e72b39b2a, bf264b20-6d00-495e-90c7-9172d4535ec7, 7543f7e8-fd5f-46d5-a310-ebae71becf44
- Package NDC
- 65145-148-01, 65145-149-01, 65145-150-01, 70512-865-02, 70512-865-15, 70512-866-05, 69315-323-08, 69315-323-15, 69315-324-05
- UNII
- 04JA59TNSJ