OLOPATADINE HYDROCHLORIDE
GLENMARK PHARMS · OLOPATADINE HYDROCHLORIDE
Open FDA's page for this record- Application number
- ANDA219557
- Sponsor name
- GLENMARK PHARMS
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20250228
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 001
- Reference drug
- No
- Brand name
- OLOPATADINE HYDROCHLORIDE
- Reference standard
- No
- Dosage form
- SOLUTION/DROPS
- Route
- OPHTHALMIC
- Marketing status
- Over-the-counter
- Active ingredients
- Name
- OLOPATADINE HYDROCHLORIDE
- Strength
- EQ 0.2% BASE
- Harmonized identifiers (openFDA)
- Application number
- ANDA219557
- Brand name
- OLOPATADINE HYDROCHLORIDE, EYE ALLERGY ITCH RELIEF
- Generic name
- OLOPATADINE HYDROCHLORIDE, EYE ALLERGY ITCH RELIEF
- Manufacturer name
- GLENMARK THERAPEUTICS INC., USA, AmerisourceBergen Drug Corp, Allegiant Health, BluePoint Laboratories, YYBA Corp
- Product NDC
- 72657-194, 46122-824, 69168-495, 68001-674, 73581-709
- Product type
- HUMAN OTC DRUG
- Route
- OPHTHALMIC
- Substance name
- OLOPATADINE HYDROCHLORIDE
- RxCUI
- 1111343
- SPL ID
- 5ce14b14-b893-4d56-a19e-b1788b17074f, 18f851e3-24c6-44fd-8376-0f5418ded9a9, bbb1ba80-f5f6-4fb5-9984-67718167625d, 4ddbb9c6-87d6-317b-e063-6294a90a7375, 49eedab1-1b39-61af-e063-6394a90a2dc6
- SPL set ID
- 07e8b359-d4ae-4b5b-81dc-c7e57e172c58, 18f851e3-24c6-44fd-8376-0f5418ded9a9, b40bf37a-da62-4ef7-8722-33a3a0f67c64, 3e86783f-0001-625f-e063-6294a90acd20, 47f8ae9b-d92b-4bcb-e063-6294a90af45a
- Package NDC
- 72657-194-25, 72657-194-11, 46122-824-29, 69168-495-77, 68001-674-92, 73581-709-02
- UNII
- 2XG66W44KF