Application 074246

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIMETIDINE	CIMETIDINE	TABLET;ORAL	200MG	No	No
002	CIMETIDINE	CIMETIDINE	TABLET;ORAL	300MG	No	No
003	CIMETIDINE	CIMETIDINE	TABLET;ORAL	400MG	No	No
004	CIMETIDINE	CIMETIDINE	TABLET;ORAL	800MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074246-001	CIMETIDINE	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17
A074246-002	CIMETIDINE	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17
A074246-003	CIMETIDINE	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17
A074246-004	CIMETIDINE	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074246-001	AB
A074246-002	AB
A074246-003	AB
A074246-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074246-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074246-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074246-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cimetidine	CIMETIDINE	Northwind Health Company, LLC	db482bd8-e68d-3a38-e053-2995a90a38a5	2026-01-01	Adverse reactions	Exact identifier application applno (ANDA): 074246 application number: ANDA074246
Cimetidine	CIMETIDINE	PD-Rx Pharmaceuticals, Inc.	28fd7158-a617-436a-8f5c-71ffbaafe527	2025-10-20	Adverse reactions	Exact identifier application applno (ANDA): 074246 application number: ANDA074246 ndc (product): 55289-581
Cimetidine	CIMETIDINE	A-S Medication Solutions	28fa98b3-6c78-4b7b-9a37-84c879dbf58a	2025-05-02	Adverse reactions	Exact identifier application applno (ANDA): 074246 application number: ANDA074246 ndc (product): 50090-3574
Cimetidine	CIMETIDINE	Mylan Pharmaceuticals Inc.	06c0a509-026f-44e0-9975-a94a8de51d43	2019-08-15	Adverse reactions	Exact identifier application applno (ANDA): 074246 application number: ANDA074246 ndc (product): 0378-0053 ndc (product): 0378-0317 ndc (product): 0378-0372 ndc (product): 0378-0541

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0053	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0053	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0053	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0053	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0317	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0317	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0317	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0317	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0372	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0372	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0372	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0372	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0541	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0541	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0541	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0541	Cimetidine	cimetidine	Mylan Pharmaceuticals Inc.	ANDA	Current
50090-3574	Cimetidine	cimetidine	A-S Medication Solutions	ANDA	Current
50090-3574	Cimetidine	cimetidine	A-S Medication Solutions	ANDA	Current
55289-581	Cimetidine	cimetidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-581	Cimetidine	cimetidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-581	Cimetidine	cimetidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-581	Cimetidine	cimetidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-581	Cimetidine	cimetidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
68151-1497	Cimetidine	cimetidine	Carilion Materials Management	ANDA	Current
70518-2809	Cimetidine	cimetidine	REMEDYREPACK INC.	ANDA	Current
70518-2809	Cimetidine	cimetidine	REMEDYREPACK INC.	ANDA	Current